Trial · NCT00433160
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) | Baseline to 52 weeks | Number of randomized participants with at least one dose of study drug and at least one post-treatment measurement. | percent change in BMD | MEAN |
| SECONDARY | Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) | Baseline to 52 Weeks | Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. | percent change in BMD | MEAN |
| SECONDARY | Percent Change in Bone Mineral Density (BMD) at Total Hip | Baseline to 52 Weeks | Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. | percent change in BMD | MEAN |
| SECONDARY | Percent Change in Bone Mineral Density (BMD) at Femoral Neck | Baseline to 52 Weeks | Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. | percent change in BMD | MEAN |
| SECONDARY | Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) | Baseline to Weeks 4, 12, 24, and 52 | Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement. | percent change in PINP | MEAN |
| SECONDARY | Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) | Baseline to Weeks 4, 12, 24, 52 | Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement. | percent change in BAP | MEAN |
| SECONDARY | Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) | Baseline to Weeks 4, 12, 24, 52 | Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. | percent change in CTX | MEAN |
| SECONDARY | Vertebral Fractures by Central X-ray Assessment | Baseline through 52 weeks | 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. | number of fractures | NUMBER |
| SECONDARY | Fractures by Investigators Assessment | Baseline through 52 Weeks | Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. | number of fractures | NUMBER |
| SECONDARY | Back Pain Severity | Baseline, Weeks 12, 24, 36, 52 | Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. | participants | NUMBER |
| SECONDARY | Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) During Open Label Phases at 76 Weeks and 104 Weeks | Baseline, 76 Weeks, 104 Weeks | Number of randomized participants with at least one dose of study drug and at least one post-treatment measurement. | percent change in BMD | MEAN |
| SECONDARY | Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) During Open Label Phases at 76 Weeks and 104 Weeks | Baseline, 76 Weeks, 104 Weeks | Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. | percent change in BMD | MEAN |
| SECONDARY | Percent Change in Bone Mineral Density (BMD) at Total Hip During Open Label Phases at 76 Weeks and 104 Weeks | Baseline, 76 Weeks, 104 Weeks | Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. | percent change in BMD | MEAN |
| SECONDARY | Percent Change in Bone Mineral Density (BMD) at Femoral Neck During Open Label Phases at 76 Weeks and 104 Weeks | Baseline, 76 Weeks, 104 Weeks | Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. | percent change in BMD | MEAN |
| 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 | Baseline, 76 Weeks, 104 Weeks | Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement. | percent change in PINP | MEAN |
| 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 | Baseline, 76 Weeks, 104 Weeks | Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement. | percent change in BAP | MEAN |
| 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 | Baseline, 76 Weeks, 104 Weeks | Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. | percent change in CTX | MEAN |
| SECONDARY | Vertebral Fractures by Central X-ray Assessment During Entire Study Period of 104 Weeks | Baseline through 104 Weeks | 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. | number of fractures | NUMBER |
| SECONDARY | Fractures by Investigators Assessment During Entire Study Period of 104 Weeks | Baseline Through 104 Weeks | Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. | number of fractures | NUMBER |
| SECONDARY | Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks | Baseline, 76 Weeks, 104 Weeks | Number of randomized participants who received at least one dose of study drug and with at least on post-treatment measurement. | participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT00433160/outcomes