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| ID | Type | Description | Link |
|---|---|---|---|
| B3D-US-GHDJ | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to use imaging technologies to demonstrate the effects of teriparatide on bone structure following 18 to 24 months of therapy in postmenopausal women with osteoporosis.
As teriparatide is approved for up to 24 months of treatment in the US, patients will be given the option to continue in a 6-month extension phase upon completion of 18 months of teriparatide treatment. This extension will allow for collection of additional bone quality data. In Canada, the use of teriparatide is currently approved for 18 months. Patients in Canada may be given the opportunity to participate in the 6-month extension phase, contingent upon Health Canada approval of the use of teriparatide treatment for 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teriparatide | Experimental | 20 micrograms (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| teriparatide | Drug | 20 mcg teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 18 Endpoint | SCR is a measure of the computed ratio of plate-like to rod-like structures in a given volume of trabecular bone and reflects the integrity of the trabecular network. The higher the value for SCR, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 18 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline. | Baseline, 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 24 Endpoint | SCR is a measure of the computed ratio of plate-like to rod-like structures in a given volume of trabecular bone and reflects the integrity of the trabecular network. The higher the value for SCR, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tucson | Arizona | 85704 |
Participants who completed the 18 month main study had an option to continue treatment for an additional 6 months (Extension Phase).
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| ID | Title | Description |
|---|---|---|
| FG000 | Teriparatide | 20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Main Study (0 - 18 Months) |
|
| |||||||||||||||||||||
| Extension Phase (18 - 24 Months) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Teriparatide | 20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 18 Endpoint | SCR is a measure of the computed ratio of plate-like to rod-like structures in a given volume of trabecular bone and reflects the integrity of the trabecular network. The higher the value for SCR, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 18 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline. | Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value. | Posted | Least Squares Mean | Standard Error | percent (%) change of ratio | Baseline, 18 months |
|
Not provided
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Teriparatide | 20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiomyopathy | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019379 | Teriparatide |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Baseline, 24 months |
| Percent Change From Baseline in Cortical Thickness (CT) in the Distal Radius at Month 18 and 24 Endpoint | Cortical thickness (CT) is the thickness of both cortices in a given volume of bone. Least squares (LS) mean of the percent change from baseline to 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline. | Baseline, 18, 24 months |
| Percent Change From Baseline in Topological Erosion Index (TEI) in the Distal Radius at Month 18 and 24 Endpoint | TEI is the ratio of the sum of topological parameters expected to increase with bone erosion compared to the sum of those expected to decrease. The lower the value for TEI, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline. | Baseline, 18, 24 months |
| Percent Change From Baseline in Bone Volume (BV)/Total Volume (TV) Ratio in the Distal Radius at Month 18 and 24 Endpoint | BV/TV is the estimate of the ratio of detectable bone relative to the total volume of the region of interest. Least squares (LS) mean of the percent change from baseline to 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline. | Baseline, 18, 24 months |
| Percent Change From Baseline in Surface-to-Curve Ratio (SCR) at Month 3, 6, 12, 18 and 24 Endpoint | SCR is a measure of the computed ratio of plate-like to rod-like structures in a given volume of trabecular bone and reflects the integrity of the trabecular network. The higher the value for SCR, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 3, 6, 12, 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline. | Baseline, 3, 6, 12, 18, 24 months |
| Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Lumbar Spine at Month 18 Endpoint | Volumetric BMD is a measure of the amount of mineral in a given volume of bone, expressed as milligram per cubic centimeter (mg/cm³). Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use. | Baseline, 18 months |
| Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Hip at Month 18 Endpoint | Volumetric BMD is a measure of the amount of mineral in a given volume of bone. Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use. | Baseline, 18 months |
| Percent Change From Baseline in the Estimate of Bone Strength of Lumbar Spine at Month 18 Endpoint | Finite Element Analysis of computed tomography (CT) data from spine is used to estimate the strength of a vertebral body using a virtual axial load. Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use. | Baseline, 18 months |
| Percent Change From Baseline in the Estimate of Bone Strength of Hip at Month 18 Endpoint | Finite Element Analysis of computed tomography (CT) data from hip is used to estimate the strength of the proximal femur with a virtual sideways fall. Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use. | Baseline, 18 months |
| Percent Change From Baseline in Areal BMD at the Lumbar Spine at Month 18 and 24 Endpoint | Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use. | Baseline, 18, 24 months |
| Percent Change From Baseline in Areal BMD at the Femoral Neck at Month 18 and 24 Endpoint | Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use. | Baseline, 18, 24 months |
| Percent Change From Baseline in Areal BMD Responses at Total Hip at Month 18 and 24 Endpoint | Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use. | Baseline, 18, 24 months |
| Percent Change From Baseline in Areal BMD at ⅓ Distal Radius at Month 18 and 24 Endpoint | Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use. | Baseline, 18, 24 months |
| Percent Change From Baseline in Areal BMD at Ultra-Distal Radius at Month 18 and 24 Endpoint | Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use. | Baseline, 18, 24 months |
| Percent Change From Baseline in Serum Procollagen Type I N-Terminal Propeptide (PINP) at Month 3, 6 and 24 Endpoint | PINP is a measure of bone formation. Least squares (LS) mean of the percent change from baseline to 3, 6, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline. | Baseline, 3, 6, 24 months |
| Percent Change From Baseline in Serum Carboxyterminal Cross-Linking Telopeptide of Type I Collagen (CTX) at Month 3, 6 and 24 Endpoint | CTX is a measure of bone resorption. Least squares (LS) mean of the percent change from baseline to 3, 6, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline. | Baseline, 3, 6, 24 months |
| United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lakewood | Colorado | 80227 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Omaha | Nebraska | 68131 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Albuquerque | New Mexico | 87106 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Pittsburgh | Pennsylvania | 15213 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Vancouver | British Columbia | V6H 3X8 | Canada |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Dominant Hand | Number | participants |
|
| Prevalent Fractures | A prevalent fracture is defined as a fracture that a participant already had at the time of study entry. One participant had both a vertebral and non-vertebral fracture and therefore the total number of participants is higher than the baseline population number. | Number | participants |
|
| Years Postmenopausal | Mean | Standard Deviation | years |
|
| Prior Bisphosphonate Use | Number | participants |
|
| Lumbar Spine T-Score | The T-score is a comparison of a patient's bone mineral density (BMD) to that of the mean BMD for a healthy population of women at peak bone mass (30 years). A normal T-score has a value of -1.0 or higher. Osteoporosis is defined as a T-score of -2.5 or lower, meaning a bone mineral density that is two and a half standard deviations below the mean BMD of a healthy population of women at peak bone mass (30 years). | Mean | Standard Deviation | units on a scale |
|
| Femoral Neck T-Score | Mean | Standard Deviation | units on a scale |
|
| Total Hip T-Score | Mean | Standard Deviation | units on a scale |
|
|
|
|
| Secondary | Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 24 Endpoint | SCR is a measure of the computed ratio of plate-like to rod-like structures in a given volume of trabecular bone and reflects the integrity of the trabecular network. The higher the value for SCR, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline. | Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value. | Posted | Least Squares Mean | Standard Error | % change of ratio | Baseline, 24 months |
|
|
|
|
| Secondary | Percent Change From Baseline in Cortical Thickness (CT) in the Distal Radius at Month 18 and 24 Endpoint | Cortical thickness (CT) is the thickness of both cortices in a given volume of bone. Least squares (LS) mean of the percent change from baseline to 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline. | Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value. | Posted | Least Squares Mean | Standard Error | % change of millimeter (mm) | Baseline, 18, 24 months |
|
|
|
|
| Secondary | Percent Change From Baseline in Topological Erosion Index (TEI) in the Distal Radius at Month 18 and 24 Endpoint | TEI is the ratio of the sum of topological parameters expected to increase with bone erosion compared to the sum of those expected to decrease. The lower the value for TEI, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline. | Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value. | Posted | Least Squares Mean | Standard Error | % change of ratio | Baseline, 18, 24 months |
|
|
|
|
| Secondary | Percent Change From Baseline in Bone Volume (BV)/Total Volume (TV) Ratio in the Distal Radius at Month 18 and 24 Endpoint | BV/TV is the estimate of the ratio of detectable bone relative to the total volume of the region of interest. Least squares (LS) mean of the percent change from baseline to 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline. | Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value. | Posted | Least Squares Mean | Standard Error | % change of ratio | Baseline, 18, 24 months |
|
|
|
|
| Secondary | Percent Change From Baseline in Surface-to-Curve Ratio (SCR) at Month 3, 6, 12, 18 and 24 Endpoint | SCR is a measure of the computed ratio of plate-like to rod-like structures in a given volume of trabecular bone and reflects the integrity of the trabecular network. The higher the value for SCR, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 3, 6, 12, 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline. | Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value. | Posted | Least Squares Mean | Standard Error | % change of ratio | Baseline, 3, 6, 12, 18, 24 months |
|
|
|
|
| Secondary | Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Lumbar Spine at Month 18 Endpoint | Volumetric BMD is a measure of the amount of mineral in a given volume of bone, expressed as milligram per cubic centimeter (mg/cm³). Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use. | Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value. | Posted | Least Squares Mean | Standard Error | % change of mg/cm³ | Baseline, 18 months |
|
|
|
|
| Secondary | Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Hip at Month 18 Endpoint | Volumetric BMD is a measure of the amount of mineral in a given volume of bone. Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use. | Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value. | Posted | Least Squares Mean | Standard Error | % change of mg/cm³ | Baseline, 18 months |
|
|
|
|
| Secondary | Percent Change From Baseline in the Estimate of Bone Strength of Lumbar Spine at Month 18 Endpoint | Finite Element Analysis of computed tomography (CT) data from spine is used to estimate the strength of a vertebral body using a virtual axial load. Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use. | Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value. | Posted | Least Squares Mean | Standard Error | % change of Newtons | Baseline, 18 months |
|
|
|
|
| Secondary | Percent Change From Baseline in the Estimate of Bone Strength of Hip at Month 18 Endpoint | Finite Element Analysis of computed tomography (CT) data from hip is used to estimate the strength of the proximal femur with a virtual sideways fall. Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use. | Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value. | Posted | Least Squares Mean | Standard Error | % change of Newtons | Baseline, 18 months |
|
|
|
|
| Secondary | Percent Change From Baseline in Areal BMD at the Lumbar Spine at Month 18 and 24 Endpoint | Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use. | Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value. | Posted | Least Squares Mean | Standard Error | % change of g/square centimeter (g/cm²) | Baseline, 18, 24 months |
|
|
|
|
| Secondary | Percent Change From Baseline in Areal BMD at the Femoral Neck at Month 18 and 24 Endpoint | Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use. | Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value. | Posted | Least Squares Mean | Standard Error | % change of g/cm² | Baseline, 18, 24 months |
|
|
|
|
| Secondary | Percent Change From Baseline in Areal BMD Responses at Total Hip at Month 18 and 24 Endpoint | Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use. | Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value. | Posted | Least Squares Mean | Standard Error | % change of g/cm² | Baseline, 18, 24 months |
|
|
|
|
| Secondary | Percent Change From Baseline in Areal BMD at ⅓ Distal Radius at Month 18 and 24 Endpoint | Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use. | Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value. | Posted | Least Squares Mean | Standard Error | % change of g/cm² | Baseline, 18, 24 months |
|
|
|
|
| Secondary | Percent Change From Baseline in Areal BMD at Ultra-Distal Radius at Month 18 and 24 Endpoint | Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use. | Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value. | Posted | Least Squares Mean | Standard Error | % change of g/cm² | Baseline, 18, 24 months |
|
|
|
|
| Secondary | Percent Change From Baseline in Serum Procollagen Type I N-Terminal Propeptide (PINP) at Month 3, 6 and 24 Endpoint | PINP is a measure of bone formation. Least squares (LS) mean of the percent change from baseline to 3, 6, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline. | Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value. | Posted | Least Squares Mean | Standard Error | % change of microgram/Liter (µg/L) | Baseline, 3, 6, 24 months |
|
|
|
|
| Secondary | Percent Change From Baseline in Serum Carboxyterminal Cross-Linking Telopeptide of Type I Collagen (CTX) at Month 3, 6 and 24 Endpoint | CTX is a measure of bone resorption. Least squares (LS) mean of the percent change from baseline to 3, 6, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline. | Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value. | Posted | Least Squares Mean | Standard Error | % change of nanogram/milliliter (ng/mL) | Baseline, 3, 6, 24 months |
|
|
|
|
| 5 |
| 35 |
| 32 |
| 35 |
| Coronary artery disease | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Neurilemmoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Injection site haematoma | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Onychoclasis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
Not provided
| D009750 |
| Nutritional and Metabolic Diseases |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
P-value is for the percent change from baseline at 24 months. |
| 95 |
| No |
| Superiority or Other |
P-value is for the percent change from baseline at 24 months. |
| 95 |
| No |
| Superiority or Other |
P-value is for the percent change from baseline at 24 months. |
| 95 |
| No |
| Superiority or Other |
| Title | Measurements |
|---|---|
|
| 18 month percent change (n=25) |
|
| 24 month percent change (n=21) |
|
P-value is for the percent change from baseline at 6 months. |
| 95 |
| No |
| Superiority or Other |
| Mixed Model Repeated Measurements | 0.610 | P-value is for the percent change from baseline at 12 months. | 95 | No | Superiority or Other |
| Mixed Model Repeated Measurements | P-value is for the percent change from baseline at 18 months. | 0.363 | 95 | No | Superiority or Other |
| Mixed Model Repeated Measurements | 0.837 | P-value is for the percent change from baseline at 24 months. | 95 | No | Superiority or Other |
P-value is for the percent change from baseline at 24 months. |
| 95 |
| No |
| Superiority or Other |
P-value is for the percent change from baseline at 24 months.
| 95 |
| No |
| Superiority or Other |
P-value is for the percent change from baseline at 24 months.
| 95 |
| No |
| Superiority or Other |
P-value is for the percent change from baseline at 24 months.
| 95 |
| No |
| Superiority or Other |
P-value is for the percent change from baseline at 24 months.
| 95 |
| No |
| Superiority or Other |
|
P-value is for the percent change from baseline at 6 months. |
| 95 |
| No |
| Superiority or Other |
| Mixed Model Repeated Measurements | <0.001 | P-value is for the percent change from baseline at 24 months. | 95 | No | Superiority or Other |
|
P-value is for the percent change from baseline at 6 months. |
| 95 |
| No |
| Superiority or Other |
| Mixed Model Repeated Measurements | 0.016 | P-value is for the percent change from baseline at 24 months. | 95 | No | Superiority or Other |