Osteoporosis
Conditions
Brief summary
Osteoporosis is a condition in which the amount of bone is reduced, the bones are weak, and there is an increased risk for fractures. Glucocorticoids (such as prednisone) are prescribed to treat a large number of conditions such as arthritis and asthma. When taken for several months or longer, glucocorticoids can cause bone loss and lead to a form of osteoporosis called glucocorticoid-induced osteoporosis. This study compared the effects of teriparatide, the study drug, with alendronate, an approved drug for treating glucocorticoid-induced osteoporosis.
Interventions
DRUGTeriparatide
20 micrograms/day, injection, 36 months
10 mg/day, oral, 36 months
DRUGPlacebo
Oral placebo, daily, 36 months
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men or women age 21 years or older * Taking on average 5.0 mg/day prednisone or equivalent for at least 3 months prior to screening
Exclusion criteria
* Taking bisphosphonates within past 6 months * More than 30 micrograms/day of estradiol or equivalent in past 3 months * History of alcoholism or drug abuse in past year * Pregnant women or nursing mothers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD) | 18 month endpoint | change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset | 18 month endpoint | change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA) |
| Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined | 3, 6, 12, 18, 24, 36 months | change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA) |
| Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset | 3, 6, 12, and 18 months | change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA) |
| Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined | 24 and 36 months and Endpoint at 36 months | change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA) |
| Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined | 18, 24, 36 months, and 18 and 36 month endpoints | change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA) |
| Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined | 18, 24, 36 months, and 18 and 36 month endpoints | change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA) |
| Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments | 1, 6, 18, and 36 months | — |
| Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined | 12, 18, 24, and 36 months | change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA) |
| Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen | 1, 6, 18, and 36 months | — |
| Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen | 1, 6, 18, and 36 months | — |
| Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase | 1, 6, 18, and 36 months | — |
| Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin | 1, 6, 18, and 36 months | — |
| Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures | 36 months | Clinical vertebral fracture was defined as a radiographically confirmed fracture that was associated with symptoms such as back pain. |
| Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined | 12, 18, 24, and 36 months | change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA) |
Countries
Austria, Belgium, Denmark, Norway, Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Teriparatide Teriparatide 20 micrograms/day injection plus oral placebo, 36 months | 214 |
| Alendronate Alendronate 10 mg/day oral plus injection placebo, 36 months | 214 |
| Total | 428 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 30 | 18 |
| Overall Study | Death | 9 | 15 |
| Overall Study | Lost to Follow-up | 4 | 13 |
| Overall Study | Other | 2 | 1 |
| Overall Study | Physician Decision | 5 | 0 |
| Overall Study | Protocol Entry Criteria Unmet | 1 | 2 |
| Overall Study | Protocol Violation | 3 | 4 |
| Overall Study | Significant Lab Value | 2 | 0 |
| Overall Study | Sponsor Decision | 6 | 1 |
| Overall Study | Withdrawal by Subject | 29 | 42 |
Baseline characteristics
| Characteristic | Teriparatide | Alendronate | Total |
|---|---|---|---|
| Age, Customized 35 <= Age < 50 years | 55 participants | 35 participants | 90 participants |
| Age, Customized 50 <= Age < 65 years | 86 participants | 93 participants | 179 participants |
| Age, Customized Age < 35 years | 13 participants | 19 participants | 32 participants |
| Age, Customized Age >= 65 years | 60 participants 1.518 | 67 participants 1.528 | 127 participants |
| Baseline Biochemical Markers of Bone Metabolism Bone-specific alkaline phosphatase | 9.465 ug/L STANDARD_DEVIATION 4.522 | 9.711 ug/L STANDARD_DEVIATION 4.527 | 9.595 ug/L STANDARD_DEVIATION 4.513 |
| Baseline Biochemical Markers of Bone Metabolism Osteocalcin | 17.130 ug/L STANDARD_DEVIATION 14.422 | 15.878 ug/L STANDARD_DEVIATION 10.286 | 16.492 ug/L STANDARD_DEVIATION 12.468 |
| Baseline Biochemical Markers of Bone Metabolism Procollagen I carboxy-terminal propeptide | 166.402 ug/L STANDARD_DEVIATION 99.625 | 152.109 ug/L STANDARD_DEVIATION 56.637 | 158.845 ug/L STANDARD_DEVIATION 79.91 |
| Baseline Biochemical Markers of Bone Metabolism Serum N-terminal propeptide of type 1 procollagen | 46.161 ug/L STANDARD_DEVIATION 35.471 | 47.235 ug/L STANDARD_DEVIATION 29.606 | 46.704 ug/L STANDARD_DEVIATION 32.562 |
| Baseline Bone Mineral Density Femoral Neck Bone Mineral Density | 0.682 grams per square centimeters STANDARD_DEVIATION 0.114 | 0.697 grams per square centimeters STANDARD_DEVIATION 0.119 | 0.689 grams per square centimeters STANDARD_DEVIATION 0.116 |
| Baseline Bone Mineral Density Lumbar Spine Bone Mineral Density | 0.845 grams per square centimeters STANDARD_DEVIATION 0.131 | 0.844 grams per square centimeters STANDARD_DEVIATION 0.128 | 0.845 grams per square centimeters STANDARD_DEVIATION 0.129 |
| Baseline Bone Mineral Density Total Hip Bone Mineral Density | 0.744 grams per square centimeters STANDARD_DEVIATION 0.113 | 0.757 grams per square centimeters STANDARD_DEVIATION 0.124 | 0.750 grams per square centimeters STANDARD_DEVIATION 0.119 |
| C-terminal telopeptide of type I collagen | 3790.483 pmol/L STANDARD_DEVIATION 2478.189 | 4543.156 pmol/L STANDARD_DEVIATION 4838.919 | 4185.328 pmol/L STANDARD_DEVIATION 3907.204 |
| Origin Caucasian | 153 participants | 148 participants | 301 participants |
| Origin Non-Caucasian | 61 participants | 66 participants | 127 participants |
| Prior Bisphosphonate User No | 194 participants | 194 participants | 388 participants |
| Prior Bisphosphonate User Yes | 20 participants | 20 participants | 40 participants |
| Region of Enrollment Argentina | 23 participants | 20 participants | 43 participants |
| Region of Enrollment Austria | 1 participants | 2 participants | 3 participants |
| Region of Enrollment Belgium | 8 participants | 8 participants | 16 participants |
| Region of Enrollment Brazil | 72 participants | 73 participants | 145 participants |
| Region of Enrollment Colombia | 10 participants | 9 participants | 19 participants |
| Region of Enrollment Denmark | 4 participants | 3 participants | 7 participants |
| Region of Enrollment Finland | 1 participants | 2 participants | 3 participants |
| Region of Enrollment Germany | 14 participants | 14 participants | 28 participants |
| Region of Enrollment Mexico | 14 participants | 15 participants | 29 participants |
| Region of Enrollment Norway | 1 participants | 1 participants | 2 participants |
| Region of Enrollment United States | 62 participants | 64 participants | 126 participants |
| Region of Enrollment Venezuela | 4 participants | 3 participants | 7 participants |
| Sex: Female, Male Female | 172 Participants | 173 Participants | 345 Participants |
| Sex: Female, Male Male | 42 Participants | 41 Participants | 83 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 190 / — | 177 / — |
| serious Total, serious adverse events | 70 / — | 64 / — |
Outcome results
Primary
Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD)
change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
Time frame: 18 month endpoint
Population: The intention-to-treat analysis was performed using all randomized and treated patients.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teriparatide | Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD) | 0.059 grams per square centimeters | Standard Error 0.006 |
| Alendronate | Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD) | 0.028 grams per square centimeters | Standard Error 0.006 |
Comparison: This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline lumbar spine bone mineral density (BMD) measurement.p-value: <0.001ANOVA
Secondary
Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures
Clinical vertebral fracture was defined as a radiographically confirmed fracture that was associated with symptoms such as back pain.
Time frame: 36 months
Population: For vertebral fractures, only those patients with baseline and postbaseline spinal radiographs were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Teriparatide | Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures | Any Fracture | 19 participants |
| Teriparatide | Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures | Nonvertebral Fracture | 16 participants |
| Teriparatide | Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures | Vertebral Fracture | 3 participants |
| Teriparatide | Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures | Clinical Vertebral Fracture | 0 participants |
| Teriparatide | Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures | Nonvertebral Fragility Fracture | 9 participants |
| Teriparatide | Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures | Severity-Radiographic Vertebral Fracture: Mild | 1 participants |
| Teriparatide | Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures | Severity-Radiographic Vertebral Fracture: Moderate | 2 participants |
| Teriparatide | Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures | Severity-Radiographic Vertebral Fracture: Severe | 0 participants |
| Alendronate | Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures | Severity-Radiographic Vertebral Fracture: Severe | 4 participants |
| Alendronate | Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures | Any Fracture | 27 participants |
| Alendronate | Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures | Nonvertebral Fragility Fracture | 5 participants |
| Alendronate | Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures | Nonvertebral Fracture | 15 participants |
| Alendronate | Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures | Severity-Radiographic Vertebral Fracture: Moderate | 2 participants |
| Alendronate | Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures | Vertebral Fracture | 13 participants |
| Alendronate | Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures | Severity-Radiographic Vertebral Fracture: Mild | 7 participants |
| Alendronate | Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures | Clinical Vertebral Fracture | 4 participants |
p-value: 0.212Cochran-Mantel-Haenszel
p-value: 0.843Cochran-Mantel-Haenszel
p-value: 0.007Cochran-Mantel-Haenszel
p-value: 0.037Cochran-Mantel-Haenszel
p-value: 0.256Cochran-Mantel-Haenszel
Secondary
Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset
change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
Time frame: 18 month endpoint
Population: The intention-to-treat analysis was performed using all randomized and treated patients (female only subset).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teriparatide | Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset | 0.056 grams per square centimeters | Standard Error 0.006 |
| Alendronate | Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset | 0.023 grams per square centimeters | Standard Error 0.006 |
Comparison: This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline lumbar spine bone mineral density (BMD) measurement.p-value: <0.001ANOVA
Secondary
Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined
change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)
Time frame: 18, 24, 36 months, and 18 and 36 month endpoints
Population: The intention-to-treat analysis was performed using all randomized and treated patients. For 18, 24 and 36 month time points, no missing data were imputed. However at the 36 month endpoint, last observation carried forward analysis was applied.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at 36 months(N=120,N=113) | 0.041 grams per square centimeters | Standard Error 0.005 |
| Teriparatide | Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined | Change, baseline to 18 month endpoint(N=185,N=176) | 0.024 grams per square centimeters | Standard Error 0.005 |
| Teriparatide | Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at 24 months(N=135,N=131) | 0.030 grams per square centimeters | Standard Error 0.005 |
| Teriparatide | Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at 18 months (N=156,N=145) | 0.028 grams per square centimeters | Standard Error 0.005 |
| Teriparatide | Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined | Change, baseline to 36 month endpoint(N=185,N=177) | 0.033 grams per square centimeters | Standard Error 0.006 |
| Alendronate | Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at 18 months (N=156,N=145) | 0.017 grams per square centimeters | Standard Error 0.005 |
| Alendronate | Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined | Change, baseline to 36 month endpoint(N=185,N=177) | 0.017 grams per square centimeters | Standard Error 0.006 |
| Alendronate | Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at 36 months(N=120,N=113) | 0.021 grams per square centimeters | Standard Error 0.005 |
| Alendronate | Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at 24 months(N=135,N=131) | 0.015 grams per square centimeters | Standard Error 0.005 |
| Alendronate | Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined | Change, baseline to 18 month endpoint(N=185,N=176) | 0.014 grams per square centimeters | Standard Error 0.005 |
Comparison: This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline femoral neck bone mineral density (BMD) measurement.p-value: <0.001ANOVA
Comparison: Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.p-value: <0.001Mixed Models Analysis
Comparison: Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.p-value: 0.002Mixed Models Analysis
Comparison: This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline femoral neck bone mineral density (BMD) measurement.p-value: 0.011ANOVA
Comparison: Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.p-value: 0.015Mixed Models Analysis
Secondary
Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined
change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
Time frame: 24 and 36 months and Endpoint at 36 months
Population: The intention-to-treat analysis was performed using all randomized and treated patients. For 24 and 36 month time points, no missing data were imputed. However, at the 36 month endpoint, last observation carried forward analysis was applied.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined | Change, baseline to 36 month endpoint(N=198,N=195) | 0.073 grams per square centimeters | Standard Error 0.008 |
| Teriparatide | Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at 36 months (N=123, N=112) | 0.090 grams per square centimeters | Standard Error 0.006 |
| Teriparatide | Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at 24 months (N=136, N=131) | 0.081 grams per square centimeters | Standard Error 0.006 |
| Alendronate | Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined | Change, baseline to 36 month endpoint(N=198,N=195) | 0.034 grams per square centimeters | Standard Error 0.008 |
| Alendronate | Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at 36 months (N=123, N=112) | 0.044 grams per square centimeters | Standard Error 0.007 |
| Alendronate | Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at 24 months (N=136, N=131) | 0.043 grams per square centimeters | Standard Error 0.006 |
Comparison: This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline lumbar spine bone mineral density (BMD) measurement.p-value: <0.001ANOVA
Comparison: Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.p-value: <0.001Mixed Models Analysis
Comparison: Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.p-value: <0.001Mixed Models Analysis
Secondary
Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined
change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)
Time frame: 18, 24, 36 months, and 18 and 36 month endpoints
Population: The intention-to-treat analysis was performed using all randomized and treated patients. For 18, 24 and 36 month time points, no missing data were imputed. However, at 18 and 36 month endpoints, last observation carried forward analyses were applied.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at 36 months(N=120,N=113) | 0.037 grams per square centimeters | Standard Error 0.005 |
| Teriparatide | Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined | Change, baseline to 18 month endpoint(N=185,N=176) | 0.026 grams per square centimeters | Standard Error 0.004 |
| Teriparatide | Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at 24 months(N=135,N=131) | 0.034 grams per square centimeters | Standard Error 0.004 |
| Teriparatide | Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at 18 months (N=156,N=144) | 0.027 grams per square centimeters | Standard Error 0.004 |
| Teriparatide | Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined | Change, baseline to 36 month endpoint(N=185,N=177) | 0.032 grams per square centimeters | Standard Error 0.005 |
| Alendronate | Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at 18 months (N=156,N=144) | 0.018 grams per square centimeters | Standard Error 0.004 |
| Alendronate | Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined | Change, baseline to 36 month endpoint(N=185,N=177) | 0.017 grams per square centimeters | Standard Error 0.005 |
| Alendronate | Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at 36 months(N=120,N=113) | 0.020 grams per square centimeters | Standard Error 0.005 |
| Alendronate | Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at 24 months(N=135,N=131) | 0.018 grams per square centimeters | Standard Error 0.004 |
| Alendronate | Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined | Change, baseline to 18 month endpoint(N=185,N=176) | 0.017 grams per square centimeters | Standard Error 0.004 |
Comparison: This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline total hip bone mineral density (BMD) measurement.p-value: <0.001ANOVA
Comparison: Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.p-value: <0.001Mixed Models Analysis
Comparison: Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.p-value: <0.001Mixed Models Analysis
Comparison: This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline total hip bone mineral density (BMD) measurement.p-value: 0.006ANOVA
Comparison: Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.p-value: 0.009Mixed Models Analysis
Secondary
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase
Time frame: 1, 6, 18, and 36 months
Population: Subset of patients with measures of biochemical markers
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase | Percent change from baseline at Month 1(N=65,N=78) | 35.0 percent | Standard Error 7.518 |
| Teriparatide | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase | Percent change from baseline at Month 6(N=66,N=76) | 52.3 percent | Standard Error 10.995 |
| Teriparatide | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase | Percent change from baseline at Month18(N=54,N=65) | 34.4 percent | Standard Error 9.548 |
| Teriparatide | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase | Percent change from baseline at Month36(N=44,N=49) | 44.7 percent | Standard Error 14.357 |
| Alendronate | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase | Percent change from baseline at Month36(N=44,N=49) | 20.6 percent | Standard Error 19.912 |
| Alendronate | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase | Percent change from baseline at Month 1(N=65,N=78) | 0.5 percent | Standard Error 4.897 |
| Alendronate | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase | Percent change from baseline at Month18(N=54,N=65) | -4.1 percent | Standard Error 10.501 |
| Alendronate | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase | Percent change from baseline at Month 6(N=66,N=76) | -7.2 percent | Standard Error 12.384 |
p-value: <0.001Wilcoxon (Mann-Whitney)
p-value: <0.001Wilcoxon (Mann-Whitney)
p-value: <0.001Wilcoxon (Mann-Whitney)
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin
Time frame: 1, 6, 18, and 36 months
Population: Subset of patients with measures of biochemical markers
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin | Percent change from baseline at Month1(N=94,N=100) | 147.1 percent | Standard Error 26.408 |
| Teriparatide | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin | Percent change from baseline at Month 6(N=84,N=88) | 120.0 percent | Standard Error 16.713 |
| Teriparatide | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin | Percent change from baseline at Month18(N=77,N=77) | 108.9 percent | Standard Error 22.75 |
| Teriparatide | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin | Percent change from baseline at Month36(N=56,N=58) | 62.1 percent | Standard Error 20.929 |
| Alendronate | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin | Percent change from baseline at Month36(N=56,N=58) | -19.6 percent | Standard Error 12.98 |
| Alendronate | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin | Percent change from baseline at Month1(N=94,N=100) | -5.2 percent | Standard Error 3.447 |
| Alendronate | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin | Percent change from baseline at Month18(N=77,N=77) | -25.0 percent | Standard Error 5.118 |
| Alendronate | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin | Percent change from baseline at Month 6(N=84,N=88) | -33.6 percent | Standard Error 3.656 |
p-value: <0.001Wilcoxon (Mann-Whitney)
p-value: <0.001Wilcoxon (Mann-Whitney)
p-value: <0.001Wilcoxon (Mann-Whitney)
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen
Time frame: 1, 6, 18, and 36 months
Population: Subset of patients with measures of biochemical markers.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen | Percent change from baseline at Month 1(N=66,N=78) | 48.2 percent | Standard Error 7.024 |
| Teriparatide | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen | Percent change from baseline at Month 6(N=67,N=76) | 10.5 percent | Standard Error 5.318 |
| Teriparatide | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen | Percent change from baseline at Month18(N=55,N=65) | 5.1 percent | Standard Error 8.604 |
| Teriparatide | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen | Percent change from baseline at Month36(N=45,N=49) | -1.3 percent | Standard Error 7.082 |
| Alendronate | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen | Percent change from baseline at Month36(N=45,N=49) | -15.4 percent | Standard Error 7.394 |
| Alendronate | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen | Percent change from baseline at Month 1(N=66,N=78) | -8.8 percent | Standard Error 2.912 |
| Alendronate | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen | Percent change from baseline at Month18(N=55,N=65) | -21.3 percent | Standard Error 4.207 |
| Alendronate | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen | Percent change from baseline at Month 6(N=67,N=76) | -22.3 percent | Standard Error 3.694 |
p-value: <0.001Wilcoxon (Mann-Whitney)
p-value: <0.001Wilcoxon (Mann-Whitney)
p-value: 0.004Wilcoxon (Mann-Whitney)
p-value: 0.013Wilcoxon (Mann-Whitney)
Secondary
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen
Time frame: 1, 6, 18, and 36 months
Population: Subset of patients with measures of biochemical markers
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen | Percent change from baseline at Month 1(N=98,N=99) | 107.0 percent | Standard Error 13.744 |
| Teriparatide | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen | Percent change from baseline at Month 6(N=86,N=85) | 130.8 percent | Standard Error 20.752 |
| Teriparatide | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen | Percent change from baseline at Month18(N=77,N=76) | 86.3 percent | Standard Error 20.231 |
| Teriparatide | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen | Percent change from baseline at Month36(N=59,N=57) | 61.7 percent | Standard Error 16.156 |
| Alendronate | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen | Percent change from baseline at Month36(N=59,N=57) | -20.2 percent | Standard Error 10.587 |
| Alendronate | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen | Percent change from baseline at Month 1(N=98,N=99) | -14.8 percent | Standard Error 2.861 |
| Alendronate | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen | Percent change from baseline at Month18(N=77,N=76) | -35.8 percent | Standard Error 4.477 |
| Alendronate | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen | Percent change from baseline at Month 6(N=86,N=85) | -43.2 percent | Standard Error 3.481 |
p-value: <0.001Wilcoxon (Mann-Whitney)
p-value: <0.001Wilcoxon (Mann-Whitney)
p-value: <0.001Wilcoxon (Mann-Whitney)
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments
Time frame: 1, 6, 18, and 36 months
Population: Subset of patients with measures of biochemical markers
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments | Percent change from baseline at Month 1(N=70,N=79) | 29.0 percent | Standard Error 8.192 |
| Teriparatide | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments | Percent change from baseline at Month 6(N=66,N=75) | 66.8 percent | Standard Error 17.143 |
| Teriparatide | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments | Percent change from baseline at Month18(N=64,N=71) | 29.1 percent | Standard Error 11.714 |
| Teriparatide | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments | Percent change from baseline at Month36(N=49,N=48) | 30.7 percent | Standard Error 14.205 |
| Alendronate | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments | Percent change from baseline at Month36(N=49,N=48) | -16.2 percent | Standard Error 23.178 |
| Alendronate | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments | Percent change from baseline at Month 1(N=70,N=79) | -38.6 percent | Standard Error 4.11 |
| Alendronate | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments | Percent change from baseline at Month18(N=64,N=71) | -47.5 percent | Standard Error 6.305 |
| Alendronate | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments | Percent change from baseline at Month 6(N=66,N=75) | -42.4 percent | Standard Error 5.05 |
p-value: <0.001Wilcoxon (Mann-Whitney)
p-value: <0.001Wilcoxon (Mann-Whitney)
p-value: <0.001Wilcoxon (Mann-Whitney)
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined
change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)
Time frame: 12, 18, 24, and 36 months
Population: The intention-to-treat analysis was performed using all randomized and treated patients. No missing data were imputed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at Month 36 (N=120,N=113) | 0.041 grams per square centimeters | Standard Error 0.005 |
| Teriparatide | Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at Month 24 (N=135,N=131) | 0.030 grams per square centimeters | Standard Error 0.005 |
| Teriparatide | Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at Month 18 (N=156,N=145) | 0.028 grams per square centimeters | Standard Error 0.005 |
| Teriparatide | Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at Month 12 (N=167,N=158) | 0.026 grams per square centimeters | Standard Error 0.005 |
| Alendronate | Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at Month 12 (N=167,N=158) | 0.012 grams per square centimeters | Standard Error 0.005 |
| Alendronate | Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at Month 36 (N=120,N=113) | 0.021 grams per square centimeters | Standard Error 0.005 |
| Alendronate | Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at Month 18 (N=156,N=145) | 0.017 grams per square centimeters | Standard Error 0.005 |
| Alendronate | Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at Month 24 (N=135,N=131) | 0.015 grams per square centimeters | Standard Error 0.005 |
Comparison: Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.p-value: <0.001Mixed Models Analysis
Comparison: Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.p-value: 0.015Mixed Models Analysis
Comparison: Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.p-value: 0.002Mixed Models Analysis
Comparison: Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.p-value: <0.001Mixed Models Analysis
Secondary
Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset
change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
Time frame: 3, 6, 12, and 18 months
Population: The intention-to-treat analysis was performed using all randomized and treated patients. No missing data were imputed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset | Change from baseline at Month 18 (N=127,N=119) | 0.062 grams per square centimeters | Standard Error 0.005 |
| Teriparatide | Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset | Change from baseline at Month 12 (N=139,N=129) | 0.052 grams per square centimeters | Standard Error 0.004 |
| Teriparatide | Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset | Change from baseline at Month 6 (N=147,N=139) | 0.031 grams per square centimeters | Standard Error 0.004 |
| Teriparatide | Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset | Change from baseline at Month 3 (N=149,N=150) | 0.017 grams per square centimeters | Standard Error 0.004 |
| Alendronate | Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset | Change from baseline at Month 3 (N=149,N=150) | 0.012 grams per square centimeters | Standard Error 0.004 |
| Alendronate | Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset | Change from baseline at Month 18 (N=127,N=119) | 0.027 grams per square centimeters | Standard Error 0.005 |
| Alendronate | Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset | Change from baseline at Month 6 (N=147,N=139) | 0.015 grams per square centimeters | Standard Error 0.004 |
| Alendronate | Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset | Change from baseline at Month 12 (N=139,N=129) | 0.024 grams per square centimeters | Standard Error 0.004 |
Comparison: Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.p-value: 0.12Mixed Models Analysis
Comparison: Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.p-value: <0.001Mixed Models Analysis
Comparison: Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.p-value: <0.001Mixed Models Analysis
Comparison: Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.p-value: <0.001Mixed Models Analysis
Secondary
Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined
change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
Time frame: 3, 6, 12, 18, 24, 36 months
Population: The intention-to-treat analysis was performed using all randomized and treated patients. No missing data were imputed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at Month 36 (N=123,N=112) | 0.090 grams per square centimeters | Standard Error 0.006 |
| Teriparatide | Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at Month 24 (N=136,N=131) | 0.081 grams per square centimeters | Standard Error 0.006 |
| Teriparatide | Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at Month 18 (N=156,N=148) | 0.066 grams per square centimeters | Standard Error 0.005 |
| Teriparatide | Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at Month 12 (N=170,N=159) | 0.054 grams per square centimeters | Standard Error 0.004 |
| Teriparatide | Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at Month 6 (N=178,N=173) | 0.034 grams per square centimeters | Standard Error 0.004 |
| Teriparatide | Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at Month 3 (N=183,N=184) | 0.019 grams per square centimeters | Standard Error 0.004 |
| Alendronate | Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at Month 6 (N=178,N=173) | 0.018 grams per square centimeters | Standard Error 0.004 |
| Alendronate | Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at Month 36 (N=123,N=112) | 0.044 grams per square centimeters | Standard Error 0.007 |
| Alendronate | Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at Month 12 (N=170,N=159) | 0.028 grams per square centimeters | Standard Error 0.004 |
| Alendronate | Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at Month 24 (N=136,N=131) | 0.043 grams per square centimeters | Standard Error 0.006 |
| Alendronate | Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at Month 3 (N=183,N=184) | 0.012 grams per square centimeters | Standard Error 0.004 |
| Alendronate | Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at Month 18 (N=156,N=148) | 0.031 grams per square centimeters | Standard Error 0.005 |
Comparison: Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.p-value: 0.058Mixed Models Analysis
Comparison: Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.p-value: <0.001Mixed Models Analysis
Comparison: Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.p-value: <0.001Mixed Models Analysis
Comparison: Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.p-value: <0.001Mixed Models Analysis
Comparison: Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.p-value: <0.001Mixed Models Analysis
Comparison: Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.p-value: <0.001Mixed Models Analysis
Secondary
Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined
change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)
Time frame: 12, 18, 24, and 36 months
Population: The intention-to-treat analysis was performed using all randomized and treated patients. No missing data was imputed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at 36 Months (N=120, N=113) | 0.037 grams per square centimeters | Standard Error 0.005 |
| Teriparatide | Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at 24 Months (N=135, N=131) | 0.034 grams per square centimeters | Standard Error 0.004 |
| Teriparatide | Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at 18 Months (N=156, N=145) | 0.027 grams per square centimeters | Standard Error 0.004 |
| Teriparatide | Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at 12 Months (N=167, N=158) | 0.022 grams per square centimeters | Standard Error 0.004 |
| Alendronate | Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at 12 Months (N=167, N=158) | 0.014 grams per square centimeters | Standard Error 0.004 |
| Alendronate | Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at 36 Months (N=120, N=113) | 0.020 grams per square centimeters | Standard Error 0.005 |
| Alendronate | Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at 18 Months (N=156, N=145) | 0.018 grams per square centimeters | Standard Error 0.004 |
| Alendronate | Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined | Change from baseline at 24 Months (N=135, N=131) | 0.018 grams per square centimeters | Standard Error 0.004 |
Comparison: Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.p-value: 0.011Mixed Models Analysis
Comparison: Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.p-value: 0.009Mixed Models Analysis
Comparison: Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.p-value: <0.001Mixed Models Analysis
Comparison: Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.p-value: <0.001Mixed Models Analysis