Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| B3D-JE-GHDB | Other Identifier | Eli Lilly and Company |
Not provided
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To evaluate the efficacy of teriparatide based on measurements of bone mineral density at lumbar spine
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teriparatide | Experimental | 20 micrograms for 104 weeks |
|
| Placebo | Placebo Comparator | Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teriparatide | Drug | daily, subcutaneous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) | Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point. | Baseline to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) | Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point. | Baseline to 52 Weeks |
| Percent Change in Bone Mineral Density (BMD) at Total Hip |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | Aichi | 454-0933 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20580870 | Result | Miyauchi A, Matsumoto T, Sugimoto T, Tsujimoto M, Warner MR, Nakamura T. Effects of teriparatide on bone mineral density and bone turnover markers in Japanese subjects with osteoporosis at high risk of fracture in a 24-month clinical study: 12-month, randomized, placebo-controlled, double-blind and 12-month open-label phases. Bone. 2010 Sep;47(3):493-502. doi: 10.1016/j.bone.2010.05.022. Epub 2010 May 24. | |
| 26185429 |
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Results from 4 patients aren't included in baseline and outcomes: 3 (2 placebo and 1 teriparatide) didn't receive study drug; 1 (placebo) had a significant good clinical practice issue of receiving study drug assigned to another patient.
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| ID | Title | Description |
|---|---|---|
| FG000 | Teriparatide | 20 micrograms for 104 weeks |
| FG001 | Placebo | Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 52-Week Double-Blind (DB) Period |
|
| ||||||||||||||||||||||||
| 76 Weeks, 24-Week Open Label (OL) Period |
| |||||||||||||||||||||||||
| 104 Weeks, 28-Week OL Period |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Teriparatide | 20 micrograms for 104 weeks |
| BG001 | Placebo | Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks |
| 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 in Bone Mineral Density at Lumbar Spine (L2-L4) | Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point. | Number of randomized participants with at least one dose of study drug and at least one post-treatment measurement. | Posted | Mean | Standard Deviation | percent change in BMD | Baseline to 52 weeks |
|
Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
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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 (During 52 Weeks) | 20 micrograms for 104 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
Original data presented were for the 52-week double-blinded treatment phase; results of the open label phases at 76 weeks and 104 weeks have now been added
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
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| Placebo | Drug | daily, subcutaneous |
|
Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point. |
| Baseline to 52 Weeks |
| Percent Change in Bone Mineral Density (BMD) at Femoral Neck | Percent change in bone mineral density at femoral neck from baseline to the last measurement point. | Baseline to 52 Weeks |
| Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) | Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point. | Baseline to Weeks 4, 12, 24, and 52 |
| Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) | Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point. | Baseline to Weeks 4, 12, 24, 52 |
| Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) | Percent change in serum type I collagen crosslinked C-telopeptide (CTX) from baseline to the individual visits and last measurement point. | Baseline to Weeks 4, 12, 24, 52 |
| Vertebral Fractures by Central X-ray Assessment | Number of vertebral fractures observed from Visit 1 (study entry) through Visit 19 (Week 52). All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment. Number of subjects with fractures and number of fractured vertebra(e) were counted. | Baseline through 52 weeks |
| Fractures by Investigators Assessment | Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment. Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident. Fractures were assessed to be "fragility" if they occurred without trauma. | Baseline through 52 Weeks |
| Back Pain Severity | Severity of back pain at baseline, individual visits and the last measurement point. Back pain was measured on a scale of 1 (none) to 4 (severe). | Baseline, Weeks 12, 24, 36, 52 |
| Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) During Open Label Phases at 76 Weeks and 104 Weeks | Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point. | Baseline, 76 Weeks, 104 Weeks |
| Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) During Open Label Phases at 76 Weeks and 104 Weeks | Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point. | Baseline, 76 Weeks, 104 Weeks |
| Percent Change in Bone Mineral Density (BMD) at Total Hip During Open Label Phases at 76 Weeks and 104 Weeks | Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point. | Baseline, 76 Weeks, 104 Weeks |
| Percent Change in Bone Mineral Density (BMD) at Femoral Neck During Open Label Phases at 76 Weeks and 104 Weeks | Percent change in bone mineral density at femoral neck from baseline to the last measurement point. | Baseline, 76 Weeks, 104 Weeks |
| Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) During Open Label Phases at 76 Weeks and 104 Weeks | Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point. | Baseline, 76 Weeks, 104 Weeks |
| Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) During Open Label Phases at 76 Weeks and 104 Weeks | Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point. | Baseline, 76 Weeks, 104 Weeks |
| Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) During Open Label Phases at 76 Weeks and 104 Weeks | Percent change in serum type I collagen crosslinked C-telepeptide (CTX) from baseline to the individual visits and last measurement point. | Baseline, 76 Weeks, 104 Weeks |
| Vertebral Fractures by Central X-ray Assessment During Entire Study Period of 104 Weeks | Number of vertebral fractures observed from Visit 1 (study entry) through 104 weeks. All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment. Number of subjects with fractures and number of fractured vertebra(e) were counted. | Baseline through 104 Weeks |
| Fractures by Investigators Assessment During Entire Study Period of 104 Weeks | Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment. Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident. Fractures were assessed to be "fragility" if they occurred without trauma. | Baseline Through 104 Weeks |
| Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks | Severity of back pain at 76 weeks and 104 weeks. Back pain was measured on a scale of 1 (none) to 4 (severe). | Baseline, 76 Weeks, 104 Weeks |
| Japan |
| 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. | Fukuoka | 811-2101 | Japan |
| 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. | Hokkaido | 070-0034 | Japan |
| 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. | Hyōgo | 655-0853 | Japan |
| 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. | Kagoshima | 890-0014 | Japan |
| 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. | Kanagawa | 231-0023 | Japan |
| 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. | Nagano | 386-0493 | Japan |
| 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. | Nagasaki | 854-0083 | Japan |
| 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. | Numakunai | 020-8505 | Japan |
| 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. | Osaka | 555-0032 | Japan |
| 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. | Ōita | 879-7125 | Japan |
| 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. | Saitama | 358-0007 | Japan |
| 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. | Shimane | 693-0021 | Japan |
| 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. | Tokushima | 770-8503 | Japan |
| 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. | Tokyo | 163-0202 | Japan |
| 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. | Tottori | 683-0853 | Japan |
| Derived |
| Yamamoto T, Tsujimoto M, Sowa H. Safety of daily teriparatide treatment: a post hoc analysis of a Phase III study to investigate the possible association of teriparatide treatment with calcium homeostasis in patients with serum procollagen type I N-terminal propeptide elevation. Clin Interv Aging. 2015 Jul 6;10:1101-9. doi: 10.2147/CIA.S83549. eCollection 2015. |
| Lost to Follow-up |
|
| Entry Criteria Exclusion |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Physician Decision |
|
| Sponsor Decision |
|
| Lack of Efficacy |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Alcohol Consumption | Number | participants |
|
| Number of Previous Vertebral Fractures | Number | participants |
|
| Previous Osteoporosis Drug Use | Number | participants |
|
| Smoking History | Number | participants |
|
| Body Mass Index | Body mass index is an estimate of body fat based on body weight divided by height squared (kg/m^2). | Mean | Standard Deviation | kilograms per square meter (kg/m^2) |
|
| Bone Mineral Density (BMD) Total Spine | Mean | Standard Deviation | grams per square centimeter (g/cm^2) |
|
| Height | Mean | Standard Deviation | centimeters (cm) |
|
| Weight | Mean | Standard Deviation | kilograms (kg) |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) | Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point. | Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. | Posted | Mean | Standard Deviation | percent change in BMD | Baseline to 52 Weeks |
|
|
|
| Secondary | Percent Change in Bone Mineral Density (BMD) at Total Hip | Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point. | Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. | Posted | Mean | Standard Deviation | percent change in BMD | Baseline to 52 Weeks |
|
|
|
| Secondary | Percent Change in Bone Mineral Density (BMD) at Femoral Neck | Percent change in bone mineral density at femoral neck from baseline to the last measurement point. | Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. | Posted | Mean | Standard Deviation | percent change in BMD | Baseline to 52 Weeks |
|
|
|
| Secondary | Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) | Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point. | Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement. | Posted | Mean | Standard Deviation | percent change in PINP | Baseline to Weeks 4, 12, 24, and 52 |
|
|
|
|
| Secondary | Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) | Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point. | Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement. | Posted | Mean | Standard Deviation | percent change in BAP | Baseline to Weeks 4, 12, 24, 52 |
|
|
|
|
| Secondary | Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) | Percent change in serum type I collagen crosslinked C-telopeptide (CTX) from baseline to the individual visits and last measurement point. | Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. | Posted | Mean | Standard Deviation | percent change in CTX | Baseline to Weeks 4, 12, 24, 52 |
|
|
|
|
| Secondary | Vertebral Fractures by Central X-ray Assessment | Number of vertebral fractures observed from Visit 1 (study entry) through Visit 19 (Week 52). All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment. Number of subjects with fractures and number of fractured vertebra(e) were counted. | Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. The n's are the number of participants with fractures. | Posted | Number | number of fractures | Baseline through 52 weeks |
|
|
|
| Secondary | Fractures by Investigators Assessment | Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment. Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident. Fractures were assessed to be "fragility" if they occurred without trauma. | Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. | Posted | Number | number of fractures | Baseline through 52 Weeks |
|
|
|
| Secondary | Back Pain Severity | Severity of back pain at baseline, individual visits and the last measurement point. Back pain was measured on a scale of 1 (none) to 4 (severe). | Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. | Posted | Number | participants | Baseline, Weeks 12, 24, 36, 52 |
|
|
|
| Secondary | Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) During Open Label Phases at 76 Weeks and 104 Weeks | Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point. | Number of randomized participants with at least one dose of study drug and at least one post-treatment measurement. | Posted | Oct 2010 | Mean | Standard Deviation | percent change in BMD | Baseline, 76 Weeks, 104 Weeks |
|
|
|
| Secondary | Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) During Open Label Phases at 76 Weeks and 104 Weeks | Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point. | Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. | Posted | Mean | Standard Deviation | percent change in BMD | Baseline, 76 Weeks, 104 Weeks |
|
|
|
| Secondary | Percent Change in Bone Mineral Density (BMD) at Total Hip During Open Label Phases at 76 Weeks and 104 Weeks | Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point. | Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. | Posted | Oct 2010 | Mean | Standard Deviation | percent change in BMD | Baseline, 76 Weeks, 104 Weeks |
|
|
|
| Secondary | Percent Change in Bone Mineral Density (BMD) at Femoral Neck During Open Label Phases at 76 Weeks and 104 Weeks | Percent change in bone mineral density at femoral neck from baseline to the last measurement point. | Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. | Posted | Oct 2010 | Mean | Standard Deviation | percent change in BMD | Baseline, 76 Weeks, 104 Weeks |
|
|
|
| Secondary | Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) During Open Label Phases at 76 Weeks and 104 Weeks | Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point. | Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement. | Posted | Oct 2010 | Mean | Standard Deviation | percent change in PINP | Baseline, 76 Weeks, 104 Weeks |
|
|
|
| Secondary | Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) During Open Label Phases at 76 Weeks and 104 Weeks | Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point. | Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement. | Posted | Oct 2010 | Mean | Standard Deviation | percent change in BAP | Baseline, 76 Weeks, 104 Weeks |
|
|
|
| Secondary | Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) During Open Label Phases at 76 Weeks and 104 Weeks | Percent change in serum type I collagen crosslinked C-telepeptide (CTX) from baseline to the individual visits and last measurement point. | Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. | Posted | Oct 2010 | Mean | Standard Deviation | percent change in CTX | Baseline, 76 Weeks, 104 Weeks |
|
|
|
| Secondary | Vertebral Fractures by Central X-ray Assessment During Entire Study Period of 104 Weeks | Number of vertebral fractures observed from Visit 1 (study entry) through 104 weeks. All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment. Number of subjects with fractures and number of fractured vertebra(e) were counted. | Number of randomized participants who received at least one dose of study drug and with at least on post-treatment measurement. The n's are the number of participants with fractures. | Posted | Oct 2010 | Number | number of fractures | Baseline through 104 Weeks |
|
|
|
| Secondary | Fractures by Investigators Assessment During Entire Study Period of 104 Weeks | Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment. Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident. Fractures were assessed to be "fragility" if they occurred without trauma. | Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. | Posted | Number | number of fractures | Baseline Through 104 Weeks |
|
|
|
| Secondary | Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks | Severity of back pain at 76 weeks and 104 weeks. Back pain was measured on a scale of 1 (none) to 4 (severe). | Number of randomized participants who received at least one dose of study drug and with at least on post-treatment measurement. | Posted | Oct 2010 | Number | participants | Baseline, 76 Weeks, 104 Weeks |
|
|
|
| 7 |
| 136 |
| 115 |
| 136 |
| EG001 | Placebo (During 52 Weeks) | Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks | 7 | 67 | 59 | 67 |
| EG002 | Teriparatide (During 76 Weeks) | 20 micrograms for 104 weeks | 10 | 136 | 123 | 136 |
| EG003 | Placebo (During 76 Weeks) | Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks | 9 | 67 | 60 | 67 |
| EG004 | Teriparatide (During 104 Weeks) | 20 micrograms for 104 weeks | 12 | 136 | 125 | 136 |
| EG005 | Placebo (During 104 Weeks) | Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks | 13 | 67 | 64 | 67 |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Bronchopulmonary aspergillosis allergic | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Brachial plexus injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chondrocalcinosis pyrophosphate | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Artery dissection | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dental care | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
Not provided
| D009750 |
| Nutritional and Metabolic Diseases |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| Percent Change to Week 24 (n=127, n=61) |
|
| Percent Change to Week 52 (n=121, n=60) |
|
| Percent Change to Last Measurement (n=136,n=66) |
|
Null hypothesis: there is no difference in the percent change in PINP after 12-week treatment between the two treatment groups. |
| Wilcoxon's Rank Sum Test |
| <0.001 |
P-value for Percent Change to Week 12. No adjustment for multiplicity was performed. |
| 95 |
| No |
| Superiority or Other |
| Null hypothesis: there is no difference in the percent change in PINP after 24-week treatment between the two treatment groups. | Wilcoxon's Rank Sum Test | <0.001 | P-value for Percent Change to Week 24. No adjustment for multiplicity was performed. | 95 | No | Superiority or Other |
| Null hypothesis: there is no difference in the percent change in PINP after 52-week treatment between the two treatment groups. | Wilcoxon's Rank Sum Test | <0.001 | P-value for Percent Change to Week 52. No adjustment for multiplicity was performed. | 95 | No | Superiority or Other |
| Null hypothesis: there is no difference in the percent change in PINP from baseline to the last measurement point between the two treatment groups. | Wilcoxon's Rank Sum Test | <0.001 | P-value for Percent Change to Last Measurement. No adjustment for multiplicity was performed. | 95 | No | Superiority or Other |
| Percent Change to Week 24 (n=127, n=60) |
|
| Percent Change to Week 52 (n=120, n=59) |
|
| Percent Change to Last Measurement (n=136, n=66) |
|
Null hypothesis: there is no difference in the percent change in BAP after 12-week treatment between the two treatment groups. |
| Wilcoxon's Rank Sum Test |
| <0.001 |
P-value for Percent Change to Week 12. No adjustment for multiplicity was performed. |
| 95 |
| No |
| Superiority or Other |
| Null hypothesis: there is no difference in the percent change in BAP after 24-week treatment between the two treatment groups. | Wilcoxon's Rank Sum Test | <0.001 | P-value for Percent Change to Week 24. No adjustment for multiplicity was performed. | 95 | No | Superiority or Other |
| Null hypothesis: there is no difference in the percent change in BAP after 52-week treatment between the two treatment groups. | Wicoxon's Rank Sum Test | 0.060 | P-value for Percent Change to Week 52. No adjustment for multiplicity was performed. | 95 | No | Superiority or Other |
| Null hypothesis: there is no difference in the percent change in BAP from baseline to the last measurement point between the two treatment groups. | Wilcoxon's Rank Sum Test | 0.130 | P-value for Percent Change to Last Measurement. No adjustment for multiplicity was performed. | 95 | No | Superiority or Other |
| Percent Change to Week 24 (n=119, n=59) |
|
| Percent Change to Week 52 (n=113, n=58) |
|
| Percent Change to Last Measurement (n=126, n=65) |
|
Null hypothesis: there is no difference in the percent change in CTX after 12-week treatment between the two treatment groups. |
| Wilcoxon's Rank Sum Test |
| <0.001 |
P-value for Percent Change to Week 12. No adjustment for multiplicity was performed. |
| 95 |
| No |
| Superiority or Other |
| Null hypothesis: there is no difference in the percent change in CTX after 24-week treatment between the two treatment groups. | Wilcoxon's Rank Sum Test | <0.001 | P-value for Percent Change to Week 24. No adjustment for multiplicity was performed. | 95 | No | Superiority or Other |
| Null hypothesis: there is no difference in the percent change in CTX after 52-week treatment between the two treatment groups. | Wilcoxon's Rank Sum Test | <0.001 | P-value for Percent Change to Week 52. No adjustment for multiplicity was performed. | 95 | No | Superiority or Other |
| Null hypothesis: there is no difference in the percent change in CTX from baseline to the last measurement point between the two treatment groups. | Wilcoxon's Rank Sum Test | <0.001 | P-value for Percent Change to Last Measurement. No adjustment for multiplicity was performed. | 95 | No | Superiority or Other |
| Non-Vertebra Fracture - Fragility |
|
| Non-Vertebra Fracture - Traumatic |
|
| Baseline: 3 - Moderate |
|
| Baseline: 4 - Severe |
|
| Week 12: 1 - None |
|
| Week 12: 2 - Mild |
|
| Week 12: 3 - Moderate |
|
| Week 12: 4 - Severe |
|
| Week 24: 1 - None |
|
| Week 24: 2 - Mild |
|
| Week 24: 3 - Moderate |
|
| Week 24: 4 - Severe |
|
| Week 36: 1 - None |
|
| Week 36: 2 - Mild |
|
| Week 36: 3 - Moderate |
|
| Week 36: 4 - Severe |
|
| Week 52: 1 - None |
|
| Week 52: 2 - Mild |
|
| Week 52: 3 - Moderate |
|
| Week 52: 4 - Severe |
|
| Last Measurement: 1 - None |
|
| Last Measurement: 2 - Mild |
|
| Last Measurement: 3 - Moderate |
|
| Last Measurement: 4 - Severe |
|
| Non-Vertebra Fracture - Fragility - 104 Weeks |
|
| Non-Vertebra Fracture - Traumatic - 104 Weeks |
|
| Week 76: 3- Moderate |
|
| Week 76: 4- Severe |
|
| Week 104: 1- None |
|
| Week 104: 2- Mild |
|
| Week 104: 3- Moderate |
|
| Week 104: 4- Severe |
|