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| ID | Type | Description | Link |
|---|---|---|---|
| B1781001 |
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The purpose of this study is to determine whether bazedoxifene acetate is safe and effective in the treatment of osteoporosis in postmenopausal women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator |
| |
| B | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bazedoxifene Acetate | Drug | BZA 20mg, daily, oral |
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| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With New Vertebral Fractures Through Month 36 | New vertebral fracture: decrease in anterior, mid, or posterior vertebral (vt) height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture. | Baseline through Month 36 |
| Percentage of Participants With New Vertebral Fractures Through Month 60 | New vertebral fracture: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture. | Baseline through Month 60 |
| Percentage of Participants With New Vertebral Fractures Through Month 84 | New vertebral fracture: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture. | Baseline through Month 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Breast Cancer Through Month 36 | Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time). | Baseline through Month 36 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Birmingham | Alabama | 35233 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20569451 | Derived | Christiansen C, Chesnut CH 3rd, Adachi JD, Brown JP, Fernandes CE, Kung AW, Palacios S, Levine AB, Chines AA, Constantine GD. Safety of bazedoxifene in a randomized, double-blind, placebo- and active-controlled Phase 3 study of postmenopausal women with osteoporosis. BMC Musculoskelet Disord. 2010 Jun 22;11:130. doi: 10.1186/1471-2474-11-130. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene acetate 20 milligram (mg) capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Core Study (Up to 3 Years) |
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| Other |
Placebo, daily, oral |
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| Incidence of Breast Cancer Through Month 60 | Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time). | Baseline through Month 60 |
| Incidence of Breast Cancer Through Month 84 | Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time). | Baseline through Month 84 |
| Percentage of Participants With New Clinical Vertebral Fractures Through Month 36 | A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base. | Baseline through Month 36 |
| Percentage of Participants With New Clinical Vertebral Fractures Through Month 60 | A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base. | Baseline through Month 60 |
| Percentage of Participants With New Clinical Vertebral Fractures Through Month 84 | A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base. | Baseline through Month 84 |
| Number of Participants With Worsening Vertebral Fractures Through Month 36 | A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline. | Baseline through Month 36 |
| Number of Participants With Worsening Vertebral Fractures Through Month 60 | A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline. | Baseline through Month 60 |
| Number of Participants With Worsening Vertebral Fractures Through Month 84 | A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline. | Baseline through Month 84 |
| Percentage of Participants With Non-vertebral Fractures Through Month 36 | Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized. | Baseline through Month 36 |
| Percentage of Participants With Non-vertebral Fractures Through Month 60 | Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized. | Baseline through Month 60 |
| Percentage of Participants With Non-vertebral Fractures Through Month 84 | Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized. | Baseline through Month 84 |
| Change From Baseline in Height at Month 36 | Height was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded). | Baseline, Month 36 |
| Change From Baseline in Height at Month 60 | Height was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded). | Baseline, Month 60 |
| Change From Baseline in Height at Month 84 | Height (cm) was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded). | Baseline, Month 84 |
| Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | BMD of lumbar spine (Lu Sp) and hip (total hip [Tl Hp], femoral neck [Fe Ne] and femur trochanter [Fe Tr]) was evaluated by dual-energy x-ray absorptiometry (DXA). The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study. Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean. Normal BMD is a T-score of -1.0 or higher. | Baseline, Months 6, 12, 18, 24, 36 |
| Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60 | BMD of lumbar spine (Lu Sp) and hip (total hip [Tl Hp], femoral neck [Fe Ne] and femur trochanter [Fe Tr]) was evaluated by dual-energy x-ray absorptiometry (DXA). The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study. Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean. Normal BMD is a T-score of -1.0 or higher. | Baseline, Month 48, 60 |
| Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 84 | BMD of lumbar spine (Lu Sp) and hip (total hip [Tl Hp], femoral neck [Fe Ne] and femur trochanter [Fe Tr]) was evaluated by dual-energy x-ray absorptiometry (DXA). The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study. Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean. Normal BMD is a T-score of -1.0 or higher. | Baseline, Month 72, 84 |
| Percent Change From Baseline in Osteocalcin at Month 3, 6 and 12 | Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels. | Baseline, Months 3, 6, 12 |
| Percent Change From Baseline in Osteocalcin at Months 36 and 60 | Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels. | Baseline, Months 36, 60 |
| Percent Change From Baseline in Osteocalcin at Months 72 and 84 | Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels. | Baseline, Months 72, 84 |
| Percent Change From Baseline in C-telopeptide (CTx) at Month 3, 6 and 12 | C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels. | Baseline, Months 3, 6, 12 |
| Percent Change From Baseline in C-telopeptide (CTx) at Months 36 and 60 | C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels. | Baseline, Months 36, 60 |
| Percent Change From Baseline in C-telopeptide (CTx) at Months 72 and 84 | C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels. | Baseline, Months 72, 84 |
| Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | Lipid parameters evaluated included total cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL), triglyceride (TG), high-density lipoprotein fraction 2 (HDL2) and high-density lipoprotein fraction 3 (HDL3). | Baseline, Months 6, 12, 24, 36 |
| Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Percentage of following indices (volume,surface,porosity) was calculated:Bone Volume(BV), Osteoid Volume(OV), Osteoid Surface(OS), Osteoclast Surface(OcS), Osteoblast Surface(ObS), Mineralizing surface(MS), Eroded Surface(ES), Osteoid Mineralizing surface(OMS), Cortical porosity(CP). | Month 36 |
| Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Percentage of following indices (volume,surface,porosity) was calculated:Bone Volume(BV), Osteoid Volume(OV), Osteoid Surface(OS), Osteoclast Surface(OcS), Osteoblast Surface(ObS), Mineralizing surface(MS), Eroded Surface(ES), Osteoid Mineralizing surface(OMS), Cortical porosity(CP). | Month 60 |
| Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Wall Thickness (WTh), Osteoid Thickness (OTh), Trabecular Thickness (TbTh), Trabecular Separation (TbSp) and Cortical thickness (CTh). Trabecular separation defined as the thickness of the spaces as defined by binarization within the volume of interest. | Month 36 |
| Bone Histomorphometric Indices at Month 60: WTh, OTh, TbTh, TbSp and CTh | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: WTh, OTh, TbTh, TbSp and CTh. Trabecular separation defined as the thickness of the spaces as defined by binarization within the volume of interest. | Month 60 |
| Bone Histomorphometric Indices at Month 36: Total Surface (Goldner Slide) [TSG] | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Total Surface (Goldner Slide) [TSG]. All specimens were demineralized and subjected to staining procedures (Goldner's staining). Slides were analyzed using light microscopy for total surface area, the surface area that consisted of bone and the surface area that consisted of graft material (all in mm^2 and expressed as percent (%) of the total surface. | Month 36 |
| Bone Histomorphometric Indices at Month 60: TSG | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Total Surface (Goldner Slide) [TSG]. All specimens were demineralized and subjected to staining procedures (Goldner's staining). Slides were analyzed using light microscopy for total surface area, the surface area that consisted of bone and the surface area that consisted of graft material (all in mm^2 and expressed as percent (%) of the total surface. | Month 60 |
| Bone Histomorphometric Indices at Month 36: TtAr | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated variable: Tissue Area (TtAr). Tissue area comprised of the porous calcified substance from which bones were made. | Month 36 |
| Bone Histomorphometric Indices at Month 60: TtAr | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated variable: Tissue Area (TtAr). Tissue area comprised of the porous calcified substance from which bones were made. | Month 60 |
| Bone Histomorphometric Indices at Month 36: BFP, RP and RmP | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Bone Formation Period (BFP), Resorption Period (RP), Remodeling Period (RmP). | Month 36 |
| Bone Histomorphometric Indices at Month 60: BFP, RP and RmP | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Bone Formation Period (BFP), Resorption Period (RP), Remodeling Period (RmP). | Month 60 |
| Bone Histomorphometric Indices at Month 36: SuD | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Surface Density (SuD). | Month 36 |
| Bone Histomorphometric Indices at Month 60: SuD | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Surface Density (SuD). | Month 60 |
| Bone Histomorphometric Indices at Month 36: BFRTS | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Form Rate (BFR)-Total Surface Reference (BFRTS). BFR accounts the bone surface which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing surface and bone surface multiplied by mineralization apposition rate (MAR). | Month 36 |
| Bone Histomorphometric Indices at Month 60: BFRTS | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Form Rate (BFR)-Total Surface Reference (BFRTS). BFR accounts the bone surface which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing surface and bone surface multiplied by mineralization apposition rate (MAR). | Month 60 |
| Bone Histomorphometric Indices at Month 36: ACF | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Activation Frequency (ACF). The total period (TP) is the duration between the beginning of one formation period (FP) and the beginning of the next FP. The number of times per year that this spot begins the FP is the activation frequency (ACF). | Month 36 |
| Bone Histomorphometric Indices at Month 60: ACF | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Activation Frequency (ACF). The total period (TP) is the duration between the beginning of one formation period (FP) and the beginning of the next FP. The number of times per year that this spot begins the FP is the activation frequency (ACF). | Month 60 |
| Bone Histomorphometric Indices at Month 36: Mlt | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineralization Lag Time (Mlt). Mineralization lag time was the lag between the time osteoid was formed and the mineral was added. | Month 36 |
| Bone Histomorphometric Indices at Month 60: Mlt | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineralization Lag Time (Mlt). Mineralization lag time was the lag between the time osteoid was formed and the mineral was added. | Month 60 |
| Bone Histomorphometric Indices at Month 36: MAR | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineral Apposition Rate (MAR). MAR is the area of new bone formed during the label interval. | Month 36 |
| Bone Histomorphometric Indices at Month 60: MAR | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineral Apposition Rate (MAR). MAR is the area of new bone formed during the label interval. | Month 60 |
| Bone Histomorphometric Indices at Month 36: TbN | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Trabecular Number (TbN). TbN= Ratio of bone volume to tissue volume divided by trabecular thickness. | Month 36 |
| Bone Histomorphometric Indices at Month 60: TbN | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Trabecular Number (TbN). TbN= Ratio of bone volume to tissue volume divided by trabecular thickness. | Month 60 |
| Bone Histomorphometric Indices at Month 36: BFRBV | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Formation Rate (BFR)-Bone Volume Reference (BFRBV). BFR accounts the bone volume which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing volume and bone volume multiplied by mineralization apposition rate (MAR). | Month 36 |
| Bone Histomorphometric Indices at Month 60: BFRBV | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Formation Rate (BFR)-Bone Volume Reference (BFRBV). BFR accounts the bone volume which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing volume and bone volume multiplied by mineralization apposition rate (MAR). | Month 60 |
| Women's Health Questionnaire (WHQ) | WHQ is a measure of mid-aged women's emotional and physical health. Consists of 36-item assessing nine domains of physical and emotional health: Depressed mood; Somatic symptoms; Anxiety/fears; Vasomotor symptoms; Sleep problems; Sexual behavior; Menstrual symptoms; Memory/concentration; and Attractiveness. Each item scored on a 4 point scale (yes definitely, yes sometimes, not much, no not at all) reduced to binary option as 0 (no) and 1 (yes). Domain subscale score was calculated as sum of domain items score divided by number of domain items. Total score was calculated as the sum of individual domain subscale score divided by number of domains. Total score range from 0 (absent) to 1 (present), with higher scores indicating more pronounced distress and dysfunction. Baseline values at different time points were considered only for the participants who were evaluable at those time points. | Baseline |
| Change From Baseline in Women's Health Questionnaire (WHQ) at Month 12, 24 and 36 | WHQ is a measure of mid-aged women's emotional and physical health. Consists of 36-item assessing nine domains of physical and emotional health: Depressed mood; Somatic symptoms; Anxiety/fears; Vasomotor symptoms; Sleep problems; Sexual behavior; Menstrual symptoms; Memory/concentration; and Attractiveness. Each item scored on a 4 point scale (yes definitely, yes sometimes, not much, no not at all) reduced to binary option as 0 (no) and 1 (yes). Domain subscale score was calculated as sum of domain items score divided by number of domain items. Total score was calculated as the sum of individual domain subscale score divided by number of domains. Total score range from 0 (absent) to 1 (present), with higher scores indicating more pronounced distress and dysfunction.Baseline values at different time points were considered only for the participants who were evaluable at those time points. | Baseline, Months 12, 24, 36 |
| European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) | QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life. Baseline values at different time points were considered only for the participants who were evaluable at those time points. | Baseline |
| Change From Baseline in European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) at Month 12, 24 and 36 | QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life. Baseline values at different time points were considered only for the participants who were evaluable at those time points. | Baseline, Months 12, 24, 36 |
| Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points. | Baseline |
| Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Month 12, 24 and 36 | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points. | Baseline, Months 12, 24, 36 |
| Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points. | Baseline |
| Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score at Month 12, 24 and 36 | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points. | Baseline, Months 12, 24, 36 |
| Birmingham |
| Alabama |
| 35249-7201 |
| United States |
| Pfizer Investigational Site | Birmingham | Alabama | 35294-3708 | United States |
| Pfizer Investigational Site | Huntsville | Alabama | 35801 | United States |
| Pfizer Investigational Site | Mobile | Alabama | 36608 | United States |
| Pfizer Investigational Site | Glendale | Arizona | 85306 | United States |
| Pfizer Investigational Site | Phoenix | Arizona | 85007 | United States |
| Pfizer Investigational Site | Phoenix | Arizona | 85013-3903 | United States |
| Pfizer Investigational Site | Phoenix | Arizona | 85013 | United States |
| Pfizer Investigational Site | Phoenix | Arizona | 85015 | United States |
| Pfizer Investigational Site | Phoenix | Arizona | 85016 | United States |
| Pfizer Investigational Site | Phoenix | Arizona | 85020 | United States |
| Pfizer Investigational Site | Phoenix | Arizona | 85027 | United States |
| Pfizer Investigational Site | Phoenix | Arizona | 85050 | United States |
| Pfizer Investigational Site | Scottsdale | Arizona | 85251 | United States |
| Pfizer Investigational Site | Scottsdale | Arizona | 85254 | United States |
| Pfizer Investigational Site | Anaheim | California | 92801 | United States |
| Pfizer Investigational Site | Berkeley | California | 94705 | United States |
| Pfizer Investigational Site | Beverly Hills | California | 90211 | United States |
| Pfizer Investigational Site | Fresno | California | 93710 | United States |
| Pfizer Investigational Site | Fresno | California | 93720 | United States |
| Pfizer Investigational Site | La Jolla | California | 92037 | United States |
| Pfizer Investigational Site | Oakland | California | 94612 | United States |
| Pfizer Investigational Site | Palm Desert | California | 92260 | United States |
| Pfizer Investigational Site | Palm Springs | California | 92260 | United States |
| Pfizer Investigational Site | Palm Springs | California | 92262 | United States |
| Pfizer Investigational Site | Palm Springs | California | 92263 | United States |
| Pfizer Investigational Site | Rancho Mirage | California | 92270 | United States |
| Pfizer Investigational Site | Sacramento | California | 95816 | United States |
| Pfizer Investigational Site | Sacramento | California | 95817 | United States |
| Pfizer Investigational Site | Sacramento | California | 95825 | United States |
| Pfizer Investigational Site | San Diego | California | 92108 | United States |
| Pfizer Investigational Site | San Diego | California | 92120 | United States |
| Pfizer Investigational Site | Upland | California | 91786 | United States |
| Pfizer Investigational Site | Whittier | California | 90602 | United States |
| Pfizer Investigational Site | Lakewood | Colorado | 80227 | United States |
| Pfizer Investigational Site | Longmont | Colorado | 80501 | United States |
| Pfizer Investigational Site | Wheat Ridge | Colorado | 80033 | United States |
| Pfizer Investigational Site | Bridgeport | Connecticut | 06606 | United States |
| Pfizer Investigational Site | Hamden | Connecticut | 06518 | United States |
| Pfizer Investigational Site | Madison | Connecticut | 06443 | United States |
| Pfizer Investigational Site | Waterbury | Connecticut | 06708 | United States |
| Pfizer Investigational Site | Newark | Delaware | 19713 | United States |
| Pfizer Investigational Site | Washington D.C. | District of Columbia | 20006 | United States |
| Pfizer Investigational Site | Washington D.C. | District of Columbia | 20007-2197 | United States |
| Pfizer Investigational Site | Washington D.C. | District of Columbia | 20007 | United States |
| Pfizer Investigational Site | Washington D.C. | District of Columbia | 20037 | United States |
| Pfizer Investigational Site | Aventura | Florida | 33180 | United States |
| Pfizer Investigational Site | Boca Raton | Florida | 33432 | United States |
| Pfizer Investigational Site | Cape Coral | Florida | 33990 | United States |
| Pfizer Investigational Site | Clearwater | Florida | 33761 | United States |
| Pfizer Investigational Site | Daytona Beach | Florida | 32114 | United States |
| Pfizer Investigational Site | Daytona Beach | Florida | 32117 | United States |
| Pfizer Investigational Site | Delray Beach | Florida | 33484 | United States |
| Pfizer Investigational Site | Fort Myers | Florida | 33916 | United States |
| Pfizer Investigational Site | Fort Myers | Florida | 33919 | United States |
| Pfizer Investigational Site | Gainesville | Florida | 32601 | United States |
| Pfizer Investigational Site | Holiday | Florida | 34690 | United States |
| Pfizer Investigational Site | Lake Worth | Florida | 33461 | United States |
| Pfizer Investigational Site | Largo | Florida | 33773 | United States |
| Pfizer Investigational Site | Ormond Beach | Florida | 32174 | United States |
| Pfizer Investigational Site | Palm Beach Gardens | Florida | 33410 | United States |
| Pfizer Investigational Site | Palm Harbor | Florida | 34684 | United States |
| Pfizer Investigational Site | Pembroke Pines | Florida | 33027 | United States |
| Pfizer Investigational Site | Pembroke Pines | Florida | 33029 | United States |
| Pfizer Investigational Site | Plantation | Florida | 33324 | United States |
| Pfizer Investigational Site | Port Orange | Florida | 32127 | United States |
| Pfizer Investigational Site | Sarasota | Florida | 34231 | United States |
| Pfizer Investigational Site | Sarasota | Florida | 34239 | United States |
| Pfizer Investigational Site | St. Petersburg | Florida | 33710 | United States |
| Pfizer Investigational Site | West Palm Beach | Florida | 33401 | United States |
| Pfizer Investigational Site | West Palm Beach | Florida | 33407 | United States |
| Pfizer Investigational Site | West Palm Beach | Florida | 33409 | United States |
| Pfizer Investigational Site | West Palm Beach | Florida | 33417 | United States |
| Pfizer Investigational Site | Augusta | Georgia | 30909 | United States |
| Pfizer Investigational Site | Decatur | Georgia | 30033 | United States |
| Pfizer Investigational Site | Riverdale | Georgia | 30274 | United States |
| Pfizer Investigational Site | Boise | Idaho | 83702 | United States |
| Pfizer Investigational Site | Boise | Idaho | 83704 | United States |
| Pfizer Investigational Site | Boise | Idaho | 83712 | United States |
| Pfizer Investigational Site | Cadwell | Idaho | 83605 | United States |
| Pfizer Investigational Site | Idaho Falls | Idaho | 83404 | United States |
| Pfizer Investigational Site | Meridian | Idaho | 83642 | United States |
| Pfizer Investigational Site | Champaign | Illinois | 61820 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60612 | United States |
| Pfizer Investigational Site | Libertyville | Illinois | 60048 | United States |
| Pfizer Investigational Site | Peoria | Illinois | 61614 | United States |
| Pfizer Investigational Site | Avon | Indiana | 46123 | United States |
| Pfizer Investigational Site | Evansville | Indiana | 47712 | United States |
| Pfizer Investigational Site | Evansville | Indiana | 47714 | United States |
| Pfizer Investigational Site | Evansville | Indiana | 47750 | United States |
| Pfizer Investigational Site | Kansas City | Kansas | 66160-7136 | United States |
| Pfizer Investigational Site | Louisville | Kentucky | 40207 | United States |
| Pfizer Investigational Site | Louisville | Kentucky | 40291 | United States |
| Pfizer Investigational Site | Lousiville | Kentucky | 40291 | United States |
| Pfizer Investigational Site | Bangor | Maine | 04401 | United States |
| Pfizer Investigational Site | Bangor | Maine | 4401 | United States |
| Pfizer Investigational Site | Bethesda | Maryland | 20817 | United States |
| Pfizer Investigational Site | Silver Spring | Maryland | 20902 | United States |
| Pfizer Investigational Site | Wheaton | Maryland | 20902 | United States |
| Pfizer Investigational Site | Boston | Massachusetts | 02115 | United States |
| Pfizer Investigational Site | Brookline | Massachusetts | 02445 | United States |
| Pfizer Investigational Site | Fall River | Massachusetts | 02720 | United States |
| Pfizer Investigational Site | Fall River | Massachusetts | 02721 | United States |
| Pfizer Investigational Site | Grand Rapids | Michigan | 49503 | United States |
| Pfizer Investigational Site | Grand Rapids | Michigan | 49546 | United States |
| Pfizer Investigational Site | Kalamazaoo | Michigan | 49048 | United States |
| Pfizer Investigational Site | Kalamazoo | Michigan | 49048 | United States |
| Pfizer Investigational Site | Brooklyn Center | Minnesota | 55430 | United States |
| Pfizer Investigational Site | Robbinsdale | Minnesota | 55422 | United States |
| Pfizer Investigational Site | Shoreview | Minnesota | 55126 | United States |
| Pfizer Investigational Site | Flowood | Mississippi | 39232 | United States |
| Pfizer Investigational Site | Jackson | Mississippi | 39216 | United States |
| Pfizer Investigational Site | Jefferson City | Missouri | 65109 | United States |
| Pfizer Investigational Site | St Louis | Missouri | 63141 | United States |
| Pfizer Investigational Site | Billings | Montana | 59101 | United States |
| Pfizer Investigational Site | Bozeman | Montana | 59715 | United States |
| Pfizer Investigational Site | Missoula | Montana | 59801 | United States |
| Pfizer Investigational Site | Missoula | Montana | 59802 | United States |
| Pfizer Investigational Site | Missoula | Montana | 59804 | United States |
| Pfizer Investigational Site | Lincoln | Nebraska | 68510 | United States |
| Pfizer Investigational Site | Henderson | Nevada | 89014 | United States |
| Pfizer Investigational Site | North Las Vegas | Nevada | 89030 | United States |
| Pfizer Investigational Site | Reno | Nevada | 89502-1196 | United States |
| Pfizer Investigational Site | Reno | Nevada | 89503 | United States |
| Pfizer Investigational Site | Manchester Twp | New Jersey | 08759 | United States |
| Pfizer Investigational Site | Ocean City | New Jersey | 07712 | United States |
| Pfizer Investigational Site | Princeton | New Jersey | 08542 | United States |
| Pfizer Investigational Site | Albuquerque | New Mexico | 87102 | United States |
| Pfizer Investigational Site | Albuquerque | New Mexico | 87106 | United States |
| Pfizer Investigational Site | Albuquerque | New Mexico | 87109 | United States |
| Pfizer Investigational Site | New Hyde Park | New York | 11042 | United States |
| Pfizer Investigational Site | New York | New York | 10029 | United States |
| Pfizer Investigational Site | The Bronx | New York | 10461 | United States |
| Pfizer Investigational Site | Charlotte | North Carolina | 28207 | United States |
| Pfizer Investigational Site | Charlotte | North Carolina | 28209 | United States |
| Pfizer Investigational Site | Charlotte | North Carolina | 28277 | United States |
| Pfizer Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| Pfizer Investigational Site | Bismarck | North Dakota | 58501 | United States |
| Pfizer Investigational Site | Bismarck | North Dakota | 58503 | United States |
| Pfizer Investigational Site | Fargo | North Dakota | 58103 | United States |
| Pfizer Investigational Site | Fargo | North Dakota | 58104 | United States |
| Pfizer Investigational Site | Jamestown | North Dakota | 58401 | United States |
| Pfizer Investigational Site | Minot | North Dakota | 58701 | United States |
| Pfizer Investigational Site | Minot | North Dakota | 58702 | United States |
| Pfizer Investigational Site | Oakes | North Dakota | 58574 | United States |
| Pfizer Investigational Site | Akron | Ohio | 44312-1647 | United States |
| Pfizer Investigational Site | Akron | Ohio | 44313 | United States |
| Pfizer Investigational Site | Centerville | Ohio | 45459 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45236 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45249 | United States |
| Pfizer Investigational Site | Cleveland | Ohio | 44122 | United States |
| Pfizer Investigational Site | Kettering | Ohio | 45459 | United States |
| Pfizer Investigational Site | Lyndhurst | Ohio | 44124 | United States |
| Pfizer Investigational Site | Mayfield Village | Ohio | 44143 | United States |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | 73102 | United States |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | 73112-4481 | United States |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | 73120 | United States |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | 73142 | United States |
| Pfizer Investigational Site | Tulsa | Oklahoma | 74135 | United States |
| Pfizer Investigational Site | Yukon | Oklahoma | 73099 | United States |
| Pfizer Investigational Site | Altoona | Pennsylvania | 16602 | United States |
| Pfizer Investigational Site | Camp Hill | Pennsylvania | 17011 | United States |
| Pfizer Investigational Site | Duncansville | Pennsylvania | 16635 | United States |
| Pfizer Investigational Site | Johnstown | Pennsylvania | 15904 | United States |
| Pfizer Investigational Site | Langhome | Pennsylvania | 19047 | United States |
| Pfizer Investigational Site | Lemoyne | Pennsylvania | 17043 | United States |
| Pfizer Investigational Site | Newtown | Pennsylvania | 18940 | United States |
| Pfizer Investigational Site | Sellersville | Pennsylvania | 18960 | United States |
| Pfizer Investigational Site | West Reading | Pennsylvania | 19611 | United States |
| Pfizer Investigational Site | Wyomissing | Pennsylvania | 19610 | United States |
| Pfizer Investigational Site | Anderson | South Carolina | 29621 | United States |
| Pfizer Investigational Site | Belton | South Carolina | 29627 | United States |
| Pfizer Investigational Site | Mt. Pleasant | South Carolina | 29464 | United States |
| Pfizer Investigational Site | Aberdeen | South Dakota | 57401 | United States |
| Pfizer Investigational Site | Sioux Falls | South Dakota | 57105 | United States |
| Pfizer Investigational Site | Waterdown | South Dakota | 57201 | United States |
| Pfizer Investigational Site | Watertown | South Dakota | 57201 | United States |
| Pfizer Investigational Site | Memphis | Tennessee | 38104 | United States |
| Pfizer Investigational Site | Memphis | Tennessee | 38119 | United States |
| Pfizer Investigational Site | Memphis | Tennessee | 38120 | United States |
| Pfizer Investigational Site | Memphis | Tennessee | 38138 | United States |
| Pfizer Investigational Site | Nashville | Tennessee | 37203 | United States |
| Pfizer Investigational Site | Bellaire | Texas | 77401 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75230-2513 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75230 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75231 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75243 | United States |
| Pfizer Investigational Site | Houston | Texas | 77030 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78220 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78229-3894 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78229 | United States |
| Pfizer Investigational Site | Temple | Texas | 76504 | United States |
| Pfizer Investigational Site | Waco | Texas | 76708 | United States |
| Pfizer Investigational Site | Salt Lake City | Utah | 84102-3015 | United States |
| Pfizer Investigational Site | Norfolk | Virginia | 23502 | United States |
| Pfizer Investigational Site | Virginia Beach | Virginia | 23454 | United States |
| Pfizer Investigational Site | Seattle | Washington | 98105-4631 | United States |
| Pfizer Investigational Site | Seattle | Washington | 98105 | United States |
| Pfizer Investigational Site | Seattle | Washington | 98133 | United States |
| Pfizer Investigational Site | Seattle | Washington | 98195 | United States |
| Pfizer Investigational Site | Spokane | Washington | 99204 | United States |
| Pfizer Investigational Site | Milwaukee | Wisconsin | 53209 | United States |
| Pfizer Investigational Site | Milwaukee | Wisconsin | 53226 | United States |
| Pfizer Investigational Site | Cheyenne | Wyoming | 82001 | United States |
| Pfizer Investigational Site | Provincia de Buenos Aires | Argentina |
| Pfizer Investigational Site | Concord | New South Wales | 2139 | Australia |
| Pfizer Investigational Site | St Leonards | New South Wales | 2065 | Australia |
| Pfizer Investigational Site | Nedlands | Western Australia | 6009 | Australia |
| Pfizer Investigational Site | Herston | QLD 4029 | Australia |
| Pfizer Investigational Site | Keswick | Australia |
| Pfizer Investigational Site | Graz | 8036 | Austria |
| Pfizer Investigational Site | Ghent | Belgium | 9000 | Belgium |
| Pfizer Investigational Site | Liège | Liege | 4000 | Belgium |
| Pfizer Investigational Site | Diepenbeek | 3590 | Belgium |
| Pfizer Investigational Site | Genk | 3600 | Belgium |
| Pfizer Investigational Site | Leuven | 3000 | Belgium |
| Pfizer Investigational Site | Schiepsebos | 6 | Belgium |
| Pfizer Investigational Site | Goiânia | Goiás | 74175-080 | Brazil |
| Pfizer Investigational Site | Duque de Caxias - Cuiaba | Mato Grosso | 78043-306 | Brazil |
| Pfizer Investigational Site | Rio de Janeiro | Rio de Janeiro | 20020-020 | Brazil |
| Pfizer Investigational Site | Rio de Janeiro | Rio de Janeiro | 22271-100 | Brazil |
| Pfizer Investigational Site | São Paulo | São Paulo | 04020-060 | Brazil |
| Pfizer Investigational Site | Sorocaba | São Paulo | 18095-450 | Brazil |
| Pfizer Investigational Site | Plovdiv | Bulgaria | 4002 | Bulgaria |
| Pfizer Investigational Site | Sofia | Bulgaria | 1301 | Bulgaria |
| Pfizer Investigational Site | Sofia | Bulgaria | 1431 | Bulgaria |
| Pfizer Investigational Site | Sofia | Bulgaria | 1504 | Bulgaria |
| Pfizer Investigational Site | Pleven | 5800 | Bulgaria |
| Pfizer Investigational Site | Plovdiv | 4002 | Bulgaria |
| Pfizer Investigational Site | Sofia | 1301 | Bulgaria |
| Pfizer Investigational Site | Sofia | 1303 | Bulgaria |
| Pfizer Investigational Site | Sofia | 1407 | Bulgaria |
| Pfizer Investigational Site | Sofia | 1431 | Bulgaria |
| Pfizer Investigational Site | Sofia | 1504 | Bulgaria |
| Pfizer Investigational Site | Calgary | Alberta | T2N 4Z6 | Canada |
| Pfizer Investigational Site | Vancouver | British Columbia | V5Z 2N6 | Canada |
| Pfizer Investigational Site | Vancouver | British Columbia | V6H 3X8 | Canada |
| Pfizer Investigational Site | Winnipeg | Manitoba | R3A 1M3 | Canada |
| Pfizer Investigational Site | Hamilton | Ontario | L8N 1Y2 | Canada |
| Pfizer Investigational Site | Hawkesbury | Ontario | K6A 1A1 | Canada |
| Pfizer Investigational Site | Hawkesbury | Ontario | K6A 3B2 | Canada |
| Pfizer Investigational Site | London | Ontario | N6A 4V2 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M5C 1R6 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M5C 2T2 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M5G 1E2 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | MB5 1W8 | Canada |
| Pfizer Investigational Site | Gatineau | Quebec | J8Y 6S9 | Canada |
| Pfizer Investigational Site | Montreal | Quebec | H2L 1S6 | Canada |
| Pfizer Investigational Site | Montreal | Quebec | H2X 1N8 | Canada |
| Pfizer Investigational Site | Pointe-Claire | Quebec | H9R 4S3 | Canada |
| Pfizer Investigational Site | Québec | Quebec | G1S 2L6 | Canada |
| Pfizer Investigational Site | Québec | Quebec | G1V 3M7 | Canada |
| Pfizer Investigational Site | Sherbrooke | Quebec | J1H 4J6 | Canada |
| Pfizer Investigational Site | Trois-Rivières | Quebec | G8Z 1Y2 | Canada |
| Pfizer Investigational Site | Saskatoon | Saskatchewan | S7K 0H6 | Canada |
| Pfizer Investigational Site | Saskatoon | Saskatchewan | S7K 1N4 | Canada |
| Pfizer Investigational Site | Santiago | Chile |
| Pfizer Investigational Site | Zadar | 23000 | Croatia |
| Pfizer Investigational Site | Zagreb | 10000 | Croatia |
| Pfizer Investigational Site | Aalborg | 9000 | Denmark |
| Pfizer Investigational Site | Ballerup Municipality | 2750 | Denmark |
| Pfizer Investigational Site | Vejle | 7100 | Denmark |
| Pfizer Investigational Site | Tallinn | 10128 | Estonia |
| Pfizer Investigational Site | Tartu | 50410 | Estonia |
| Pfizer Investigational Site | Tartu | 51010 | Estonia |
| Pfizer Investigational Site | Tartu | Estonia |
| Pfizer Investigational Site | Oulu | Finland | 90 100 | Finland |
| Pfizer Investigational Site | Jyväskylä | FIN | 40100 | Finland |
| Pfizer Investigational Site | Jyväskylä | 40700 | Finland |
| Pfizer Investigational Site | Jyväskylä | FIN-40100 | Finland |
| Pfizer Investigational Site | Kuopio | 70210 | Finland |
| Pfizer Investigational Site | Kuopio | 70211 | Finland |
| Pfizer Investigational Site | Kuopio | FIN-70211 | Finland |
| Pfizer Investigational Site | Lahti | Finland |
| Pfizer Investigational Site | Turku | 20100 | Finland |
| Pfizer Investigational Site | Lyon | 69437 | France |
| Pfizer Investigational Site | Orléans | 45032 | France |
| Pfizer Investigational Site | Paris | 75015 | France |
| Pfizer Investigational Site | Berlin | 12200 | Germany |
| Pfizer Investigational Site | München | 80809 | Germany |
| Pfizer Investigational Site | Zerbst | 39261 | Germany |
| Pfizer Investigational Site | Athens | Greece | 11526 | Greece |
| Pfizer Investigational Site | Hong Kong | Hong Kong |
| Pfizer Investigational Site | PRC | Hong Kong |
| Pfizer Investigational Site | Sai Ying Pung | Hong Kong |
| Pfizer Investigational Site | Békéscsaba | 5600 | Hungary |
| Pfizer Investigational Site | H-6720 Szeged | Hungary |
| Pfizer Investigational Site | Kecskemét | 6000 | Hungary |
| Pfizer Investigational Site | Makó | 6900 | Hungary |
| Pfizer Investigational Site | Roma | 00136 | Italy |
| Pfizer Investigational Site | Roma | 00168 | Italy |
| Pfizer Investigational Site | Roma | 00189 | Italy |
| Pfizer Investigational Site | Siena | 53100 | Italy |
| Pfizer Investigational Site | Kaunas | LT-50009 | Lithuania |
| Pfizer Investigational Site | Vilnius | LT-04130 | Lithuania |
| Pfizer Investigational Site | Vilnius | LT-10318 | Lithuania |
| Pfizer Investigational Site | Seccion de Lomas Verdes | State of Mexico | CP 53120 | Mexico |
| Pfizer Investigational Site | Mexico City | 03100 | Mexico |
| Pfizer Investigational Site | Mexico City | 11800 | Mexico |
| Pfizer Investigational Site | Emmen | Drenthe | 7824 AA | Netherlands |
| Pfizer Investigational Site | Nijmegen | GA | 6525 | Netherlands |
| Pfizer Investigational Site | Amsterdam | HV | 1081 | Netherlands |
| Pfizer Investigational Site | Nijmegen | SZ | 6532 | Netherlands |
| Pfizer Investigational Site | Eindhoven | 5611 NJ | Netherlands |
| Pfizer Investigational Site | Rotterdam | 3001 HG | Netherlands |
| Pfizer Investigational Site | Milford | Auckland | New Zealand |
| Pfizer Investigational Site | Christchurch | NZ | 8143 | New Zealand |
| Pfizer Investigational Site | Auckland | New Zealand |
| Pfizer Investigational Site | Dunedin | New Zealand |
| Pfizer Investigational Site | Bergen | NO-5094 | Norway |
| Pfizer Investigational Site | Hamar | 2317 | Norway |
| Pfizer Investigational Site | Oslo | NO-0164 | Norway |
| Pfizer Investigational Site | Oslo | NO-0176 | Norway |
| Pfizer Investigational Site | Trondheim | 7006 | Norway |
| Pfizer Investigational Site | Trondheim | NO-7006 | Norway |
| Pfizer Investigational Site | Krakow | Krakow | 30-510 | Poland |
| Pfizer Investigational Site | Katowice | Poland | 40-084 | Poland |
| Pfizer Investigational Site | Warsaw | Poland | 03-335 | Poland |
| Pfizer Investigational Site | Wroclaw | Poland | 50-088 | Poland |
| Pfizer Investigational Site | Krakow | 30-007 | Poland |
| Pfizer Investigational Site | Krakow | 30-017 | Poland |
| Pfizer Investigational Site | Krakow | 30-224 | Poland |
| Pfizer Investigational Site | Krakow | 31-501 | Poland |
| Pfizer Investigational Site | Lublin | 20-090 | Poland |
| Pfizer Investigational Site | Warsaw | 00-315 | Poland |
| Pfizer Investigational Site | Warsaw | 00-418 | Poland |
| Pfizer Investigational Site | Warsaw | 00-655 | Poland |
| Pfizer Investigational Site | Warsaw | 00-699 | Poland |
| Pfizer Investigational Site | Warsaw | 00-909 | Poland |
| Pfizer Investigational Site | Warsaw | 02-341 | Poland |
| Pfizer Investigational Site | Warsaw | 02-796 | Poland |
| Pfizer Investigational Site | Warsaw | 04-730 | Poland |
| Pfizer Investigational Site | Iași | Iaşi | 700111 | Romania |
| Pfizer Investigational Site | Cluj-Napoca | Napoca | 400000 | Romania |
| Pfizer Investigational Site | Bucharest | 050521 | Romania |
| Pfizer Investigational Site | Bucharest | 7000 | Romania |
| Pfizer Investigational Site | Bucharest | 70231 | Romania |
| Pfizer Investigational Site | Bucharesti | 7000 | Romania |
| Pfizer Investigational Site | Cluj-Napoca | 400349 | Romania |
| Pfizer Investigational Site | Moscow | 101990 | Russia |
| Pfizer Investigational Site | Moscow | 107014 | Russia |
| Pfizer Investigational Site | Moscow | 115522 | Russia |
| Pfizer Investigational Site | Moscow | 117036 | Russia |
| Pfizer Investigational Site | Moscow | 119002 | Russia |
| Pfizer Investigational Site | Moscow | 121356 | Russia |
| Pfizer Investigational Site | Moscow | 127299 | Russia |
| Pfizer Investigational Site | Moscow | 129010 | Russia |
| Pfizer Investigational Site | Saint Petersburg | 1190068 | Russia |
| Pfizer Investigational Site | Saint Petersburg | 190068 | Russia |
| Pfizer Investigational Site | Saint Petersburg | 194291 | Russia |
| Pfizer Investigational Site | Saint Petersburg | 199034 | Russia |
| Pfizer Investigational Site | Piešťany | Slovak Republic | Slovakia |
| Pfizer Investigational Site | Bratislava | 826 06 | Slovakia |
| Pfizer Investigational Site | Bratislava | 833 01 | Slovakia |
| Pfizer Investigational Site | Bratislava | 83301 | Slovakia |
| Pfizer Investigational Site | Bratislava | 851 07 | Slovakia |
| Pfizer Investigational Site | Groenkloof | Pretoria | South Africa |
| Pfizer Investigational Site | Johannesburg | South Africa | 2193 | South Africa |
| Pfizer Investigational Site | Pretoria | South Africa | 0181 | South Africa |
| Pfizer Investigational Site | Bedford Gardens | South Africa |
| Pfizer Investigational Site | Johannesburg | 2193 | South Africa |
| Pfizer Investigational Site | Johannesburg | 2196 | South Africa |
| Pfizer Investigational Site | Johannesburg | South Africa |
| Pfizer Investigational Site | Parow | 7500 | South Africa |
| Pfizer Investigational Site | Parow | South Africa |
| Pfizer Investigational Site | Pretoria | 0042 | South Africa |
| Pfizer Investigational Site | Pretoria | South Africa |
| Pfizer Investigational Site | Somerset West | South Africa |
| Pfizer Investigational Site | Stellenbosch | South Africa |
| Pfizer Investigational Site | Madrid | Madrid | 28046 | Spain |
| Pfizer Investigational Site | Madrid | Spain | 28009 | Spain |
| Pfizer Investigational Site | Madrid | 28006 | Spain |
| Pfizer Investigational Site | Madrid | 28009 | Spain |
| Pfizer Investigational Site | Madrid | 28040 | Spain |
| Bazedoxifene 40 mg (Core) |
Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| FG002 | Raloxifene 60 mg (Core) | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| FG003 | Placebo (Core+SE I+SE II) | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| FG004 | Bazedoxifene 40/20 mg (SE I) | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| FG005 | Bazedoxifene 20 mg (SE II) | Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| TREATED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Completed Core Study, Entered SE I |
|
|
| Study Extension I |
|
|
| Completed SE I, Entered Extension SE II |
|
|
| Study Extension II |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. |
| BG001 | Bazedoxifene 40 mg (Core) | Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| BG002 | Raloxifene 60 mg (Core) | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| BG003 | Placebo (Core+SE I+SE II) | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Height | Height (cm) was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded). Number of participants analyzed (N) = 1883, 1869, 1848, 1883 for each arm group. | Mean | Standard Deviation | centimeter (cm) |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants With New Vertebral Fractures Through Month 36 | New vertebral fracture: decrease in anterior, mid, or posterior vertebral (vt) height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture. | Intent-to-treat(ITT) population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.N (number of participants analyzed)=participants evaluable for this measure.n=participants with specified baseline fracture status evaluable for each group. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline through Month 36 |
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| Primary | Percentage of Participants With New Vertebral Fractures Through Month 60 | New vertebral fracture: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture. | ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.N (number of participants analyzed)=participants evaluable for this measure.n=participants with specified baseline fracture status evaluable for each group. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline through Month 60 |
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| Primary | Percentage of Participants With New Vertebral Fractures Through Month 84 | New vertebral fracture: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture. | Modified ITT(mITT) population of safety population category one(SP1) population:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.N (number of participants analyzed)=participants evaluable.n=participants with specified baseline fracture status. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline through Month 84 |
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| Secondary | Incidence of Breast Cancer Through Month 36 | Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time). | Safety Population 1 (SP1) included all randomized participants who received at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Posted | Number | Breast cancer per 1000-women years | Baseline through Month 36 |
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| Secondary | Incidence of Breast Cancer Through Month 60 | Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time). | SP1 included all randomized participants who received at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Posted | Number | Breast cancer per 1000-women years | Baseline through Month 60 |
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| Secondary | Incidence of Breast Cancer Through Month 84 | Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time). | SP1 included all randomized participants who received at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Posted | Number | Breast cancer per 1000-women years | Baseline through Month 84 |
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| Secondary | Percentage of Participants With New Clinical Vertebral Fractures Through Month 36 | A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base. | ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline through Month 36 |
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| Secondary | Percentage of Participants With New Clinical Vertebral Fractures Through Month 60 | A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base. | ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline through Month 60 |
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| Secondary | Percentage of Participants With New Clinical Vertebral Fractures Through Month 84 | A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base. | mITT population of SP1 population included all randomized participants who took at least 1 dose of test article and who had a vertebral radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline through Month 84 |
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| Secondary | Number of Participants With Worsening Vertebral Fractures Through Month 36 | A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline. | ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | Participants | Baseline through Month 36 |
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| Secondary | Number of Participants With Worsening Vertebral Fractures Through Month 60 | A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline. | ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | Participants | Baseline through Month 60 |
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| Secondary | Number of Participants With Worsening Vertebral Fractures Through Month 84 | A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline. | mITT population of SP1 population included all randomized participants who took at least 1 dose of test article and who had a vertebral radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | Participants | Baseline through Month 84 |
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| Secondary | Percentage of Participants With Non-vertebral Fractures Through Month 36 | Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized. | ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline through Month 36 |
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| Secondary | Percentage of Participants With Non-vertebral Fractures Through Month 60 | Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized. | ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline through Month 60 |
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| Secondary | Percentage of Participants With Non-vertebral Fractures Through Month 84 | Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized. | mITT population of SP1 population:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline through Month 84 |
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| Secondary | Change From Baseline in Height at Month 36 | Height was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded). | ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. N (number of participants analyzed)=participants evaluable for this measure. | Posted | Least Squares Mean | Standard Error | millimeter (mm) | Baseline, Month 36 |
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| Secondary | Change From Baseline in Height at Month 60 | Height was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded). | ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. N (number of participants analyzed)=participants evaluable for this measure. | Posted | Least Squares Mean | Standard Error | mm | Baseline, Month 60 |
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| Secondary | Change From Baseline in Height at Month 84 | Height (cm) was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded). | mITT population of SP1 population:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Posted | Mean | Standard Deviation | mm | Baseline, Month 84 |
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| Secondary | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | BMD of lumbar spine (Lu Sp) and hip (total hip [Tl Hp], femoral neck [Fe Ne] and femur trochanter [Fe Tr]) was evaluated by dual-energy x-ray absorptiometry (DXA). The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study. Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean. Normal BMD is a T-score of -1.0 or higher. | ITT population included all randomized participants who took at least 1 dose of test article; had baseline BMD and at least one valid BMD while on therapy. N (number of participants analyzed)=participants evaluable for this measure.n=participants with specified baseline fracture status evaluable for each group. | Posted | Least Squares Mean | Standard Error | Percent change | Baseline, Months 6, 12, 18, 24, 36 |
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| Secondary | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60 | BMD of lumbar spine (Lu Sp) and hip (total hip [Tl Hp], femoral neck [Fe Ne] and femur trochanter [Fe Tr]) was evaluated by dual-energy x-ray absorptiometry (DXA). The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study. Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean. Normal BMD is a T-score of -1.0 or higher. | mITT population of SP1 population:randomized participants who took at least 1 dose of test article; had baseline BMD and at least one valid BMD while on therapy. N (number of participants analyzed)=participants evaluable for this measure.n=participants with specified baseline fracture status evaluable for each group. | Posted | Least Squares Mean | Standard Error | Percent change | Baseline, Month 48, 60 |
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| Secondary | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 84 | BMD of lumbar spine (Lu Sp) and hip (total hip [Tl Hp], femoral neck [Fe Ne] and femur trochanter [Fe Tr]) was evaluated by dual-energy x-ray absorptiometry (DXA). The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study. Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean. Normal BMD is a T-score of -1.0 or higher. | Modified ITT(mITT) population of SP1 population:randomized participants who took at least 1 dose of test article;had baseline BMD and at least one valid BMD while on therapy. N (number of participants analyzed)=participants evaluable.n=participants with specified baseline fracture status. | Posted | Mean | Standard Deviation | Percent change | Baseline, Month 72, 84 |
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| Secondary | Percent Change From Baseline in Osteocalcin at Month 3, 6 and 12 | Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels. | ITT population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is signifying those participants who were evaluable for this measure at the specified time point for each arm group. | Posted | Median | Inter-Quartile Range | Percent change | Baseline, Months 3, 6, 12 |
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| Secondary | Percent Change From Baseline in Osteocalcin at Months 36 and 60 | Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels. | mITT of SP1 population included all randomized participants who took at least 1 dose of test article.'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is signifying those participants who were evaluable for this measure at the specified time point for each arm group. | Posted | Median | Inter-Quartile Range | Percent change | Baseline, Months 36, 60 |
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| Secondary | Percent Change From Baseline in Osteocalcin at Months 72 and 84 | Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels. | mITT of SP1 population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Posted | Median | Inter-Quartile Range | Percent change | Baseline, Months 72, 84 |
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| Secondary | Percent Change From Baseline in C-telopeptide (CTx) at Month 3, 6 and 12 | C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels. | ITT population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is signifying those participants who were evaluable for this measure at the specified time point for each arm group. | Posted | Median | Inter-Quartile Range | Percent change | Baseline, Months 3, 6, 12 |
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| Secondary | Percent Change From Baseline in C-telopeptide (CTx) at Months 36 and 60 | C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels. | mITT of SP1 population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is signifying those participants who were evaluable for this measure at the specified time point for each arm group. | Posted | Median | Inter-Quartile Range | Percent change | Baseline, Months 36, 60 |
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| Secondary | Percent Change From Baseline in C-telopeptide (CTx) at Months 72 and 84 | C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels. | mITT of SP1 population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Posted | Median | Inter-Quartile Range | Percent change | Baseline, Months 72, 84 |
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| Secondary | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | Lipid parameters evaluated included total cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL), triglyceride (TG), high-density lipoprotein fraction 2 (HDL2) and high-density lipoprotein fraction 3 (HDL3). | ITT population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is signifying those participants who were evaluable for this measure at the specified time point for each arm group. | Posted | Median | Inter-Quartile Range | Percent change | Baseline, Months 6, 12, 24, 36 |
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| Secondary | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Percentage of following indices (volume,surface,porosity) was calculated:Bone Volume(BV), Osteoid Volume(OV), Osteoid Surface(OS), Osteoclast Surface(OcS), Osteoblast Surface(ObS), Mineralizing surface(MS), Eroded Surface(ES), Osteoid Mineralizing surface(OMS), Cortical porosity(CP). | ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group. | Posted | Least Squares Mean | Standard Error | Percentage of indices | Month 36 |
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| Secondary | Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Percentage of following indices (volume,surface,porosity) was calculated:Bone Volume(BV), Osteoid Volume(OV), Osteoid Surface(OS), Osteoclast Surface(OcS), Osteoblast Surface(ObS), Mineralizing surface(MS), Eroded Surface(ES), Osteoid Mineralizing surface(OMS), Cortical porosity(CP). | ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group. | Posted | Least Squares Mean | Standard Error | Percentage of indices | Month 60 |
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| Secondary | Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Wall Thickness (WTh), Osteoid Thickness (OTh), Trabecular Thickness (TbTh), Trabecular Separation (TbSp) and Cortical thickness (CTh). Trabecular separation defined as the thickness of the spaces as defined by binarization within the volume of interest. | ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group. | Posted | Least Squares Mean | Standard Error | micrometer (mcm) | Month 36 |
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| Secondary | Bone Histomorphometric Indices at Month 60: WTh, OTh, TbTh, TbSp and CTh | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: WTh, OTh, TbTh, TbSp and CTh. Trabecular separation defined as the thickness of the spaces as defined by binarization within the volume of interest. | ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group. | Posted | Least Squares Mean | Standard Error | mcm | Month 60 |
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| Secondary | Bone Histomorphometric Indices at Month 36: Total Surface (Goldner Slide) [TSG] | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Total Surface (Goldner Slide) [TSG]. All specimens were demineralized and subjected to staining procedures (Goldner's staining). Slides were analyzed using light microscopy for total surface area, the surface area that consisted of bone and the surface area that consisted of graft material (all in mm^2 and expressed as percent (%) of the total surface. | ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. | Posted | Least Squares Mean | Standard Error | millimeter (mm) | Month 36 |
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| Secondary | Bone Histomorphometric Indices at Month 60: TSG | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Total Surface (Goldner Slide) [TSG]. All specimens were demineralized and subjected to staining procedures (Goldner's staining). Slides were analyzed using light microscopy for total surface area, the surface area that consisted of bone and the surface area that consisted of graft material (all in mm^2 and expressed as percent (%) of the total surface. | ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. | Posted | Least Squares Mean | Standard Error | mm | Month 60 |
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| Secondary | Bone Histomorphometric Indices at Month 36: TtAr | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated variable: Tissue Area (TtAr). Tissue area comprised of the porous calcified substance from which bones were made. | ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. | Posted | Least Squares Mean | Standard Error | Square millimeter (mm^2) | Month 36 |
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| Secondary | Bone Histomorphometric Indices at Month 60: TtAr | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated variable: Tissue Area (TtAr). Tissue area comprised of the porous calcified substance from which bones were made. | ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. | Posted | Least Squares Mean | Standard Error | mm^2 | Month 60 |
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| Secondary | Bone Histomorphometric Indices at Month 36: BFP, RP and RmP | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Bone Formation Period (BFP), Resorption Period (RP), Remodeling Period (RmP). | ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group. | Posted | Least Squares Mean | Standard Error | years (yrs) | Month 36 |
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| Secondary | Bone Histomorphometric Indices at Month 60: BFP, RP and RmP | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Bone Formation Period (BFP), Resorption Period (RP), Remodeling Period (RmP). | ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group. | Posted | Least Squares Mean | Standard Error | yrs | Month 60 |
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| Secondary | Bone Histomorphometric Indices at Month 36: SuD | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Surface Density (SuD). | ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. | Posted | Least Squares Mean | Standard Error | square millimeter per cubic millimeter | Month 36 |
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| Secondary | Bone Histomorphometric Indices at Month 60: SuD | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Surface Density (SuD). | ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. | Posted | Least Squares Mean | Standard Error | square millimeter per cubic millimeter | Month 60 |
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| Secondary | Bone Histomorphometric Indices at Month 36: BFRTS | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Form Rate (BFR)-Total Surface Reference (BFRTS). BFR accounts the bone surface which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing surface and bone surface multiplied by mineralization apposition rate (MAR). | ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. | Posted | Least Squares Mean | Standard Error | cubic millimetre/square millimetre/year | Month 36 |
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| Secondary | Bone Histomorphometric Indices at Month 60: BFRTS | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Form Rate (BFR)-Total Surface Reference (BFRTS). BFR accounts the bone surface which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing surface and bone surface multiplied by mineralization apposition rate (MAR). | ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. | Posted | Least Squares Mean | Standard Error | cubic millimetre/square millimetre/year | Month 60 |
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| Secondary | Bone Histomorphometric Indices at Month 36: ACF | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Activation Frequency (ACF). The total period (TP) is the duration between the beginning of one formation period (FP) and the beginning of the next FP. The number of times per year that this spot begins the FP is the activation frequency (ACF). | ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. | Posted | Least Squares Mean | Standard Error | Activation of bone formation/year | Month 36 |
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| Secondary | Bone Histomorphometric Indices at Month 60: ACF | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Activation Frequency (ACF). The total period (TP) is the duration between the beginning of one formation period (FP) and the beginning of the next FP. The number of times per year that this spot begins the FP is the activation frequency (ACF). | ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. | Posted | Least Squares Mean | Standard Error | Activation of bone formation/year | Month 60 |
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| Secondary | Bone Histomorphometric Indices at Month 36: Mlt | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineralization Lag Time (Mlt). Mineralization lag time was the lag between the time osteoid was formed and the mineral was added. | ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. | Posted | Least Squares Mean | Standard Error | days | Month 36 |
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| Secondary | Bone Histomorphometric Indices at Month 60: Mlt | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineralization Lag Time (Mlt). Mineralization lag time was the lag between the time osteoid was formed and the mineral was added. | ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. | Posted | Least Squares Mean | Standard Error | days | Month 60 |
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| Secondary | Bone Histomorphometric Indices at Month 36: MAR | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineral Apposition Rate (MAR). MAR is the area of new bone formed during the label interval. | ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. | Posted | Least Squares Mean | Standard Error | mcm/days (mcm/d) | Month 36 |
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| Secondary | Bone Histomorphometric Indices at Month 60: MAR | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineral Apposition Rate (MAR). MAR is the area of new bone formed during the label interval. | ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. | Posted | Least Squares Mean | Standard Error | mcm/d | Month 60 |
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| Secondary | Bone Histomorphometric Indices at Month 36: TbN | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Trabecular Number (TbN). TbN= Ratio of bone volume to tissue volume divided by trabecular thickness. | ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. | Posted | Least Squares Mean | Standard Error | ratio/millimeter (ratio/mm) | Month 36 |
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| Secondary | Bone Histomorphometric Indices at Month 60: TbN | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Trabecular Number (TbN). TbN= Ratio of bone volume to tissue volume divided by trabecular thickness. | ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. | Posted | Least Squares Mean | Standard Error | ratio/mm | Month 60 |
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| Secondary | Bone Histomorphometric Indices at Month 36: BFRBV | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Formation Rate (BFR)-Bone Volume Reference (BFRBV). BFR accounts the bone volume which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing volume and bone volume multiplied by mineralization apposition rate (MAR). | ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. | Posted | Least Squares Mean | Standard Error | square millimetre/square millimetre/year | Month 36 |
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| Secondary | Bone Histomorphometric Indices at Month 60: BFRBV | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Formation Rate (BFR)-Bone Volume Reference (BFRBV). BFR accounts the bone volume which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing volume and bone volume multiplied by mineralization apposition rate (MAR). | ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. | Posted | Least Squares Mean | Standard Error | square millimetre/square millimetre/year | Month 60 |
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| Secondary | Women's Health Questionnaire (WHQ) | WHQ is a measure of mid-aged women's emotional and physical health. Consists of 36-item assessing nine domains of physical and emotional health: Depressed mood; Somatic symptoms; Anxiety/fears; Vasomotor symptoms; Sleep problems; Sexual behavior; Menstrual symptoms; Memory/concentration; and Attractiveness. Each item scored on a 4 point scale (yes definitely, yes sometimes, not much, no not at all) reduced to binary option as 0 (no) and 1 (yes). Domain subscale score was calculated as sum of domain items score divided by number of domain items. Total score was calculated as the sum of individual domain subscale score divided by number of domains. Total score range from 0 (absent) to 1 (present), with higher scores indicating more pronounced distress and dysfunction. Baseline values at different time points were considered only for the participants who were evaluable at those time points. | ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants who were evaluable for this measure at the specified time point for each arm group. | Posted | Mean | Standard Deviation | Units on a scale | Baseline |
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| Secondary | Change From Baseline in Women's Health Questionnaire (WHQ) at Month 12, 24 and 36 | WHQ is a measure of mid-aged women's emotional and physical health. Consists of 36-item assessing nine domains of physical and emotional health: Depressed mood; Somatic symptoms; Anxiety/fears; Vasomotor symptoms; Sleep problems; Sexual behavior; Menstrual symptoms; Memory/concentration; and Attractiveness. Each item scored on a 4 point scale (yes definitely, yes sometimes, not much, no not at all) reduced to binary option as 0 (no) and 1 (yes). Domain subscale score was calculated as sum of domain items score divided by number of domain items. Total score was calculated as the sum of individual domain subscale score divided by number of domains. Total score range from 0 (absent) to 1 (present), with higher scores indicating more pronounced distress and dysfunction.Baseline values at different time points were considered only for the participants who were evaluable at those time points. | ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants who were evaluable for this measure at the specified time point for each arm group. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Months 12, 24, 36 |
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| Secondary | European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) | QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life. Baseline values at different time points were considered only for the participants who were evaluable at those time points. | ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants who were evaluable for this measure at the specified time point for each arm group. | Posted | Mean | Standard Deviation | Units on a scale | Baseline |
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| Secondary | Change From Baseline in European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) at Month 12, 24 and 36 | QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life. Baseline values at different time points were considered only for the participants who were evaluable at those time points. | ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants who were evaluable for this measure at the specified time point for each arm group. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Months 12, 24, 36 |
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| Secondary | Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points. | ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants who were evaluable for this measure at the specified time point for each arm group. | Posted | Mean | Standard Deviation | millimeter (mm) | Baseline |
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| Secondary | Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Month 12, 24 and 36 | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points. | ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants who were evaluable for this measure at the specified time point for each arm group. | Posted | Least Squares Mean | Standard Error | mm | Baseline, Months 12, 24, 36 |
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| Secondary | Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points. | ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants who were evaluable for this measure at the specified time point for each arm group. | Posted | Mean | Standard Deviation | Units on a scale | Baseline |
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| Secondary | Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score at Month 12, 24 and 36 | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points. | ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants who were evaluable for this measure at the specified time point for each arm group. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Months 12, 24, 36 |
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Not provided
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bazedoxifene 20 mg | Bazedoxifene acetate 20 mg capsule orally once daily along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily in core study, study extension I and II. | 507 | 1,886 | 1,818 | 1,886 | ||
| EG001 | Bazedoxifene 40/ 20 mg | Bazedoxifene acetate 40 mg capsule orally once daily in the core study, in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, and II along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | 468 | 1,872 | 1,800 | 1,872 | ||
| EG002 | Raloxifene 60 mg (Core Study) | Raloxifene 60 mg capsule orally once daily in the core study along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | 393 | 1,849 | 1,775 | 1,849 | ||
| EG003 | Placebo | Matching placebo capsule orally once daily along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily in the core study, study extension I and II. | 479 | 1,885 | 1,823 | 1,885 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | General disorders | COSTART | Non-systematic Assessment |
| |
| Abdominal syndrome acute | General disorders | COSTART | Non-systematic Assessment |
| |
| Abscess | General disorders | COSTART | Non-systematic Assessment |
| |
| Accidental injury | General disorders | COSTART | Non-systematic Assessment |
| |
| Accidental overdose | General disorders | COSTART | Non-systematic Assessment |
| |
| Adenoma | General disorders | COSTART | Non-systematic Assessment |
| |
| Allergic reaction | General disorders | COSTART | Non-systematic Assessment |
| |
| Anaphylactoid reaction | General disorders | COSTART | Non-systematic Assessment |
| |
| Asthenia | General disorders | COSTART | Non-systematic Assessment |
| |
| Back pain | General disorders | COSTART | Non-systematic Assessment |
| |
| Carcinoma | General disorders | COSTART | Non-systematic Assessment |
| |
| Cellulitis | General disorders | COSTART | Non-systematic Assessment |
| |
| Chest pain | General disorders | COSTART | Non-systematic Assessment |
| |
| Chest pain substernal | General disorders | COSTART | Non-systematic Assessment |
| |
| Collagen disorder | General disorders | COSTART | Non-systematic Assessment |
| |
| Cyst | General disorders | COSTART | Non-systematic Assessment |
| |
| Death | General disorders | COSTART | Non-systematic Assessment |
| |
| Fever | General disorders | COSTART | Non-systematic Assessment |
| |
| Fibrosis | General disorders | COSTART | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | COSTART | Non-systematic Assessment |
| |
| Headache | General disorders | COSTART | Non-systematic Assessment |
| |
| Hernia | General disorders | COSTART | Non-systematic Assessment |
| |
| Human immunodeficiency virus test positive | General disorders | COSTART | Non-systematic Assessment |
| |
| Hormone level altered | General disorders | COSTART | Non-systematic Assessment |
| |
| Hydrocephalus | General disorders | COSTART | Non-systematic Assessment |
| |
| Hyperplasia | General disorders | COSTART | Non-systematic Assessment |
| |
| Infection | General disorders | COSTART | Non-systematic Assessment |
| |
| Lab test abnormal | General disorders | COSTART | Non-systematic Assessment |
| |
| Malaise | General disorders | COSTART | Non-systematic Assessment |
| |
| Neck pain | General disorders | COSTART | Non-systematic Assessment |
| |
| Neoplasm | General disorders | COSTART | Non-systematic Assessment |
| |
| Non-specified drug reaction | General disorders | COSTART | Non-systematic Assessment |
| |
| Overdose | General disorders | COSTART | Non-systematic Assessment |
| |
| Pain | General disorders | COSTART | Non-systematic Assessment |
| |
| Peritonitis | General disorders | COSTART | Non-systematic Assessment |
| |
| Sarcoma | General disorders | COSTART | Non-systematic Assessment |
| |
| Sepsis | General disorders | COSTART | Non-systematic Assessment |
| |
| Septic shock | General disorders | COSTART | Non-systematic Assessment |
| |
| Suicide attempt | General disorders | COSTART | Non-systematic Assessment |
| |
| Aneurysm | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Aortic stenosis | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Arterial anomaly | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Arterial thrombosis | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Arteriosclerosis | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| AV block | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| AV block complete | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| AV block second degree | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Cardiomegaly | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Cardiovascular disorder | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Carotid occlusion | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Carotid thrombosis | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Cerebral hemorrhage | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Cerebral infarct | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Cerebral ischemia | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Cerebral thrombosis | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Cerebrovascular accident | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Cerebrovascular disorder | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Congestive heart failure | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Coronary artery disorder | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Coronary occlusion | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Deep vein thrombosis | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Electrocardiogram abnormal | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Embolus lower extremity | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Extrasystoles | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Heart arrest | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Heart block | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Heart failure | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Hemorrhage | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Hypertension | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Hypertensive encephalopathy | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Hypotension | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Infarct | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Intracranial aneurysm | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Intracranial hemorrhage | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Mesenteric occlusion | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Migraine | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Myocardial infarct | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Myocardial ischemia | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Palpitation | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Peripheral gangrene | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Peripheral vascular disorder | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Phlebitis | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Pulmonary embolus | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Pulmonary hypertension | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Retinal artery occlusion | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Retinal vein thrombosis | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Shock | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Sick sinus syndrome | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Subarachnoid hemorrhage | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Syncope | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Tachycardia sinus | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Thrombophlebitis superficial | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Thrombosis | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Valvular heart disease | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Varicose vein | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Vascular disorder | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Vascular purpura | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Vasculitis | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Biliary pain | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Blood in stool | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Carcinoma of mouth | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Cholangitis | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Cholecystitis | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Cholelithiasis | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Cholestatic jaundice | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Cleft palate | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Duodenal ulcer perforation | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Esophageal stenosis | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Fecal impaction | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Fecal incontinence | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Gastroenteritis | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Gastrointestinal carcinoma | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Gastrointestinal hemorrhage | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| GI neoplasia | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Hematemesis | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Hemorrhage of colon | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Hemorrhagic gastritis | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Hemorrhagic pancreatitis | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Hepatic neoplasia | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Hepatitis | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Hepatomegaly | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Hiatal hernia | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Ileitis | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Jaundice | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Liver damage | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Liver function tests abnormal | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Malabsorption syndrome | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Megacolon | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Pancreas disorder | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Periodontitis | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Pyloric stenosis | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Rectal disorder | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Sialadenitis | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Stomach ulcer | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Stomach ulcer hemorrhage | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Ulcerative colitis | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Adh inappropriate | Endocrine disorders | COSTART | Non-systematic Assessment |
| |
| Diabetes mellitus | Endocrine disorders | COSTART | Non-systematic Assessment |
| |
| Goiter | Endocrine disorders | COSTART | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | COSTART | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | COSTART | Non-systematic Assessment |
| |
| Parathyroid disorder | Endocrine disorders | COSTART | Non-systematic Assessment |
| |
| Thyroid adenoma | Endocrine disorders | COSTART | Non-systematic Assessment |
| |
| Thyroid carcinoma | Endocrine disorders | COSTART | Non-systematic Assessment |
| |
| Thyroid disorder | Endocrine disorders | COSTART | Non-systematic Assessment |
| |
| Thyroid neoplasia | Endocrine disorders | COSTART | Non-systematic Assessment |
| |
| Thyroiditis | Endocrine disorders | COSTART | Non-systematic Assessment |
| |
| Acute myeloblastic leukemia | Blood and lymphatic system disorders | COSTART | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | COSTART | Non-systematic Assessment |
| |
| Chronic lymphocytic leukemia | Blood and lymphatic system disorders | COSTART | Non-systematic Assessment |
| |
| Ecchymosis | Blood and lymphatic system disorders | COSTART | Non-systematic Assessment |
| |
| Iron deficiency anemia | Blood and lymphatic system disorders | COSTART | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | COSTART | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | COSTART | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | COSTART | Non-systematic Assessment |
| |
| Lymphocytosis | Blood and lymphatic system disorders | COSTART | Non-systematic Assessment |
| |
| Lymphoma | Blood and lymphatic system disorders | COSTART | Non-systematic Assessment |
| |
| Lymphoma like reaction | Blood and lymphatic system disorders | COSTART | Non-systematic Assessment |
| |
| Myeloma | Blood and lymphatic system disorders | COSTART | Non-systematic Assessment |
| |
| Myeloproliferative disorder | Blood and lymphatic system disorders | COSTART | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | COSTART | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | COSTART | Non-systematic Assessment |
| |
| Petechiae | Blood and lymphatic system disorders | COSTART | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | COSTART | Non-systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | COSTART | Non-systematic Assessment |
| |
| Alkaline phosphatase increased | Metabolism and nutrition disorders | COSTART | Non-systematic Assessment |
| |
| Bilirubinemia | Metabolism and nutrition disorders | COSTART | Non-systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | COSTART | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | COSTART | Non-systematic Assessment |
| |
| Edema | Metabolism and nutrition disorders | COSTART | Non-systematic Assessment |
| |
| Electrolyte abnormality | Metabolism and nutrition disorders | COSTART | Non-systematic Assessment |
| |
| Healing abnormal | Metabolism and nutrition disorders | COSTART | Non-systematic Assessment |
| |
| Hypercholesteremia | Metabolism and nutrition disorders | COSTART | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | COSTART | Non-systematic Assessment |
| |
| Hyperlipemia | Metabolism and nutrition disorders | COSTART | Non-systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | COSTART | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | COSTART | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | COSTART | Non-systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | COSTART | Non-systematic Assessment |
| |
| Peripheral edema | Metabolism and nutrition disorders | COSTART | Non-systematic Assessment |
| |
| Serum glutamic oxaloacetic transaminase increased | Metabolism and nutrition disorders | COSTART | Non-systematic Assessment |
| |
| Serum glutamic pyruvic transaminase increased | Metabolism and nutrition disorders | COSTART | Non-systematic Assessment |
| |
| Weight gain | Metabolism and nutrition disorders | COSTART | Non-systematic Assessment |
| |
| Weight loss | Metabolism and nutrition disorders | COSTART | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Arthrosis | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Bone disorder | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Chondrodystrophy | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Joint disorder | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Leg cramps | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Meniscus lesion | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Musculoskeletal anomaly | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Myasthenia | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Myopathy | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Spinal fracture | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Tendinous contracture | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Tendon rupture | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Addiction | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Alcoholism | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Amnesia | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Anxiety | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Apathy | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Aphasia | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Central nervous system neoplasia | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Confusion | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Dementia | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Depression | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Emotional lability | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Extrapyramidal syndrome | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Facial paresis | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Hallucinations | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Hemiplegia | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Hypesthesia | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Manic depressive reaction | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Mental status changes | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Nerve compression | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Neuritis | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Neuropathy | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Ophthalmoplegia | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Paralysis | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Paresis | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Paresthesia | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Personality disorder | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Radiculopathy nos | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Speech disorder | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Subdural hematoma | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Suicidal ideation | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Suicide | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Vertebrobasilar insufficiency | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Vertigo | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Carcinoma of lung | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Chronic obstructive airways disease | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Cough increased | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Hemothorax | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Laryngeal neoplasia | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Laryngitis | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Lung edema | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Pleural disorder | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Sinusitis | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | COSTART | Non-systematic Assessment |
| |
| Discoid lupus erythematosus | Skin and subcutaneous tissue disorders | COSTART | Non-systematic Assessment |
| |
| Fungal dermatitis | Skin and subcutaneous tissue disorders | COSTART | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | COSTART | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | COSTART | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | COSTART | Non-systematic Assessment |
| |
| Skin benign neoplasm | Skin and subcutaneous tissue disorders | COSTART | Non-systematic Assessment |
| |
| Skin carcinoma | Skin and subcutaneous tissue disorders | COSTART | Non-systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | COSTART | Non-systematic Assessment |
| |
| Skin melanoma | Skin and subcutaneous tissue disorders | COSTART | Non-systematic Assessment |
| |
| Skin necrosis | Skin and subcutaneous tissue disorders | COSTART | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | COSTART | Non-systematic Assessment |
| |
| Subcutaneous nodule | Skin and subcutaneous tissue disorders | COSTART | Non-systematic Assessment |
| |
| Sweating | Skin and subcutaneous tissue disorders | COSTART | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | COSTART | Non-systematic Assessment |
| |
| Abnormal vision | General disorders | COSTART | Non-systematic Assessment |
| |
| Blindness transient | General disorders | COSTART | Non-systematic Assessment |
| |
| Cataract specified | General disorders | COSTART | Non-systematic Assessment |
| |
| Deafness | General disorders | COSTART | Non-systematic Assessment |
| |
| Ear disorder | General disorders | COSTART | Non-systematic Assessment |
| |
| Eye disorder | General disorders | COSTART | Non-systematic Assessment |
| |
| Eye hemorrhage | General disorders | COSTART | Non-systematic Assessment |
| |
| Glaucoma | General disorders | COSTART | Non-systematic Assessment |
| |
| Keratitis | General disorders | COSTART | Non-systematic Assessment |
| |
| Ophthalmitis | General disorders | COSTART | Non-systematic Assessment |
| |
| Optic neuritis | General disorders | COSTART | Non-systematic Assessment |
| |
| Otitis media | General disorders | COSTART | Non-systematic Assessment |
| |
| Retinal degeneration | General disorders | COSTART | Non-systematic Assessment |
| |
| Retinal detachment | General disorders | COSTART | Non-systematic Assessment |
| |
| Retinal disorder | General disorders | COSTART | Non-systematic Assessment |
| |
| Tinnitus | General disorders | COSTART | Non-systematic Assessment |
| |
| Vestibular disorder | General disorders | COSTART | Non-systematic Assessment |
| |
| Vitreous disorder | General disorders | COSTART | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Acute kidney failure | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Anuria | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Bladder carcinoma | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Bladder neoplasm | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Breast carcinoma | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Breast cyst | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Breast disorder | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Breast enlargement | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Breast neoplasm | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Cervix carcinoma | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Cervix carcinoma in situ | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Cervix disorder | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Cervix neoplasm | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Cystitis | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Endometrial carcinoma | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Endometrial disorder | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Endometrial hyperplasia | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Endometrial neoplasia | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Genital leukoplakia | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Kidney calculus | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Kidney failure | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Kidney function abnormal | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Ovarian carcinoma | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Ovarian cyst | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Ovarian disorder | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Ovarian germ cell teratoma benign | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Pyelonephritis | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Urinary tract disorder | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Urinary tract infection | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Urination impaired | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Urogenital anomaly | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Urogenital disorder | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Urolithiasis | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Uterine disorder | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Uterine fibroids enlarged | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Vaginitis | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Vulvovaginal disorder | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Reaction unevaluable | General disorders | COSTART | Non-systematic Assessment |
| |
| Adverse event associated with miscellaneous factors | General disorders | COSTART | Non-systematic Assessment |
| |
| Allergic reaction other than drug | General disorders | COSTART | Non-systematic Assessment |
| |
| Device malfunction | General disorders | COSTART | Non-systematic Assessment |
| |
| Local reaction to procedure | Skin and subcutaneous tissue disorders | COSTART | Non-systematic Assessment |
| |
| Surgical procedure | Surgical and medical procedures | COSTART | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | General disorders | COSTART | Non-systematic Assessment |
| |
| Accidental injury | General disorders | COSTART | Non-systematic Assessment |
| |
| Asthenia | General disorders | COSTART | Non-systematic Assessment |
| |
| Back pain | General disorders | COSTART | Non-systematic Assessment |
| |
| Chest pain | General disorders | COSTART | Non-systematic Assessment |
| |
| Flu syndrome | General disorders | COSTART | Non-systematic Assessment |
| |
| Headache | General disorders | COSTART | Non-systematic Assessment |
| |
| Infection | General disorders | COSTART | Non-systematic Assessment |
| |
| Neck pain | General disorders | COSTART | Non-systematic Assessment |
| |
| Pain | General disorders | COSTART | Non-systematic Assessment |
| |
| Hypertension | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Vasodilatation | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Gastroenteritis | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Hypercholesteremia | Metabolism and nutrition disorders | COSTART | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | COSTART | Non-systematic Assessment |
| |
| Hyperlipemia | Metabolism and nutrition disorders | COSTART | Non-systematic Assessment |
| |
| Peripheral edema | Metabolism and nutrition disorders | COSTART | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Arthrosis | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Leg cramps | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Anxiety | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Depression | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Insomnia | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Paresthesia | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Vertigo | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Cough increased | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Sinusitis | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | COSTART | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | COSTART | Non-systematic Assessment |
| |
| Cataract specified | General disorders | COSTART | Non-systematic Assessment |
| |
| Breast disorder | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Cervix disorder | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Cystitis | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Urinary tract infection | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Vaginitis | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Adverse event associated with miscellaneous factors | General disorders | COSTART | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C447119 | bazedoxifene |
Not provided
Not provided
Not provided
| Other Event |
|
| Death |
|
| Withdrawal by Subject |
|
| Protocol Violation |
|
| Lack of Efficacy |
|
| Failed to return |
|
| Other Event |
|
| Withdrawn as per protocol |
|
| Death |
|
| Withdrawal by Subject |
|
| Protocol Violation |
|
| Lack of Efficacy |
|
| Failed to return |
|
| Other Event |
|
| Enrolled but not treated |
|
| Male |
|
| At Least 1 Prevalent Fracture (n=967,942,954,981) |
|
No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40 mg [Core] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs. |
| Log Rank |
| 0.24 |
| Hazard Ratio (HR) |
| 0.647 |
| 2-Sided |
| 95 |
| 0.322 |
| 1.301 |
| No |
| Superiority or Other |
| No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40 mg [Core] versus Raloxifene 60 mg [Core]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | Log Rank | 0.83 | Hazard Ratio (HR) | 1.097 | 2-Sided | 95 | 0.501 | 2.405 | No | Superiority or Other |
| No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Raloxifene 60 mg [Core]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | Log Rank | 0.87 | Hazard Ratio (HR) | 1.074 | 2-Sided | 95 | 0.490 | 2.356 | No | Superiority or Other |
| No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Bazedoxifene 40 mg [Core]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | Log Rank | 0.96 | Hazard Ratio (HR) | 0.988 | 2-Sided | 95 | 0.458 | 2.131 | No | Superiority or Other |
| No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Raloxifene 60 mg [Core] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | Log Rank | 0.16 | Hazard Ratio (HR) | 0.592 | 2-Sided | 95 | 0.289 | 1.212 | No | Superiority or Other |
| At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | Log Rank | 0.035 | Hazard Ratio (HR) | 0.551 | 2-Sided | 95 | 0.324 | 0.937 | No | Superiority or Other |
| At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40 mg [Core] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | Log Rank | 0.070 | Hazard Ratio (HR) | 0.624 | 2-Sided | 95 | 0.373 | 1.045 | No | Superiority or Other |
| At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40 mg [Core] versus Raloxifene 60 mg [Core]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | Log Rank | 0.79 | Hazard Ratio (HR) | 1.085 | 2-Sided | 95 | 0.605 | 1.947 | No | Superiority or Other |
| At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Raloxifene 60 mg [Core]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | Log Rank | 0.99 | Hazard Ratio (HR) | 0.959 | 2-Sided | 95 | 0.527 | 1.743 | No | Superiority or Other |
| At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Bazedoxifene 40 mg [Core]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | Log Rank | 0.78 | Hazard Ratio (HR) | 0.882 | 2-Sided | 95 | 0.488 | 1.593 | No | Superiority or Other |
| At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Raloxifene 60 mg [Core] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | Log Rank | 0.036 | Hazard Ratio (HR) | 0.574 | 2-Sided | 95 | 0.340 | 0.968 | No | Superiority or Other |
| OG002 | Bazedoxifene 40/20 mg (SE I) | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
|
|
|
Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
|
|
|
Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| OG003 | Placebo (Core+SE I+SE II) | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
|
|
|
Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| OG002 | Raloxifene 60 mg (Core) | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| OG003 | Placebo (Core+SE I+SE II) | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
|
|
|
| OG002 | Bazedoxifene 40/20 mg (SE I) | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
|
|
|
|
|
|
| Raloxifene 60 mg (Core) |
Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| OG003 | Placebo (Core+SE I+SE II) | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
|
|
| OG002 | Bazedoxifene 40/20 mg (SE I) | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
|
|
|
|
| OG003 | Placebo (Core+SE I+SE II) | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
|
|
|
Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
|
|
|
| Counts |
|---|
| Participants |
|
|
|
| OG003 | Placebo (Core+SE I+SE II) | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
|
|
|
|
|
|
| Participants |
|
|
|
| OG002 | Raloxifene 60 mg (Core) | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| OG003 | Placebo (Core+SE I+SE II) | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
|
|
|
| OG002 | Bazedoxifene 40/20 mg (SE I) | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
|
|
|
|
|
|
| OG003 | Placebo (Core+SE I+SE II) | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
|
|
|
Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
|
|
|
| Participants |
|
|
|
| OG003 | Placebo (Core+SE I+SE II) | Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
|
|
|
Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
|
|
|
| Participants |
|
|
|
Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| OG003 | Placebo (Core+SE I+SE II) | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
|
|
|
Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
| OG002 | Raloxifene 60 mg (Core) | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| OG003 | Placebo (Core+SE I+SE II) | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
|
|
|
Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
| OG002 | Bazedoxifene 40/20 mg (SE I) | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
|
|
|
| OG002 | Raloxifene 60 mg (Core) | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| OG003 | Placebo (Core+SE I+SE II) | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
|
|
|
| OG002 | Bazedoxifene 40/20 mg (SE I) | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
|
|
|
Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
| OG002 | Raloxifene 60 mg (Core) | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| OG003 | Placebo (Core+SE I+SE II) | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
|
|
|
| OG002 | Bazedoxifene 40/20 mg (SE I) | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
|
|
|
| OG002 |
| Raloxifene 60 mg (Core) |
Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| OG003 | Placebo (Core+SE I+SE II) | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
|
|
|
| OG002 | Bazedoxifene 40/20 mg (SE I) | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
|
|
|
| OG002 | Raloxifene 60 mg (Core) | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| OG003 | Placebo (Core+SE I+SE II) | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
|
|
|
| OG002 | Bazedoxifene 40/20 mg (SE I) | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
|
|
|
| Raloxifene 60 mg (Core) |
Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| OG003 | Placebo (Core+SE I+SE II) | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
|
|
|
| OG002 | Bazedoxifene 40/20 mg (SE I) | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
|
|
|
| OG002 | Raloxifene 60 mg (Core) | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| OG003 | Placebo (Core+SE I+SE II) | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
|
|
|
| OG002 | Bazedoxifene 40/20 mg (SE I) | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
|
|
|
| OG002 | Raloxifene 60 mg (Core) | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| OG003 | Placebo (Core+SE I+SE II) | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
|
|
|
| OG002 | Bazedoxifene 40/20 mg (SE I) | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
|
|
|
| OG002 |
| Raloxifene 60 mg (Core) |
Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| OG003 | Placebo (Core+SE I+SE II) | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
|
|
|
| OG002 | Bazedoxifene 40/20 mg (SE I) | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
|
|
|
| OG002 |
| Raloxifene 60 mg (Core) |
Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| OG003 | Placebo (Core+SE I+SE II) | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
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| OG002 | Bazedoxifene 40/20 mg (SE I) | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
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| OG002 |
| Raloxifene 60 mg (Core) |
Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| OG003 | Placebo (Core+SE I+SE II) | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
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| OG002 | Bazedoxifene 40/20 mg (SE I) | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
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| OG002 | Raloxifene 60 mg (Core) | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| OG003 | Placebo (Core+SE I+SE II) | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
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| OG002 | Bazedoxifene 40/20 mg (SE I) | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
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| OG001 | Bazedoxifene 40 mg (Core) | Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| OG002 | Raloxifene 60 mg (Core) | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| OG003 | Placebo (Core+SE I+SE II) | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
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| OG001 | Bazedoxifene 40 mg (Core) | Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| OG002 | Raloxifene 60 mg (Core) | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| OG003 | Placebo (Core+SE I+SE II) | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
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Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| OG002 | Raloxifene 60 mg (Core) | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| OG003 | Placebo (Core+SE I+SE II) | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
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| Bazedoxifene 40 mg (Core) |
Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| OG002 | Raloxifene 60 mg (Core) | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| OG003 | Placebo (Core+SE I+SE II) | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
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| OG002 | Raloxifene 60 mg (Core) | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| OG003 | Placebo (Core+SE I+SE II) | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
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| OG002 | Raloxifene 60 mg (Core) | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| OG003 | Placebo (Core+SE I+SE II) | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
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Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| OG002 | Raloxifene 60 mg (Core) | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| OG003 | Placebo (Core+SE I+SE II) | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
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| Bazedoxifene 40 mg (Core) |
Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| OG002 | Raloxifene 60 mg (Core) | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| OG003 | Placebo (Core+SE I+SE II) | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
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