Trial · NCT00433160
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) | Baseline to 52 weeks | Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point. |
| Secondary | Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) | Baseline to 52 Weeks | Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point. |
| Secondary | Percent Change in Bone Mineral Density (BMD) at Total Hip | Baseline to 52 Weeks | Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point. |
| Secondary | Percent Change in Bone Mineral Density (BMD) at Femoral Neck | Baseline to 52 Weeks | Percent change in bone mineral density at femoral neck from baseline to the last measurement point. |
| Secondary | Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) | Baseline to Weeks 4, 12, 24, and 52 | Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point. |
| Secondary | Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) | Baseline to Weeks 4, 12, 24, 52 | Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point. |
| Secondary | Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) | Baseline to Weeks 4, 12, 24, 52 | Percent change in serum type I collagen crosslinked C-telopeptide (CTX) from baseline to the individual visits and last measurement point. |
| Secondary | Vertebral Fractures by Central X-ray Assessment | Baseline through 52 weeks | 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. |
| Secondary | Fractures by Investigators Assessment | Baseline through 52 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. |
| Secondary | Back Pain Severity | Baseline, Weeks 12, 24, 36, 52 | 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). |
| 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 | Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point. |
| 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 | Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point. |
| 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 | Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point. |
| 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 | Percent change in bone mineral density at femoral neck from baseline to the last measurement point. |
| 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 | Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point. |
| 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 | Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point. |
| 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 | Percent change in serum type I collagen crosslinked C-telepeptide (CTX) from baseline to the individual visits and last measurement point. |
| Secondary | Vertebral Fractures by Central X-ray Assessment During Entire Study Period of 104 Weeks | Baseline through 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. |
| Secondary | Fractures by Investigators Assessment During Entire Study Period of 104 Weeks | Baseline Through 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. |
| Secondary | Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks | Baseline, 76 Weeks, 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). |
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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