Trial · NCT03512262
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Lumbar Spine BMD at Month 12 | Baseline, Month 12 | Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory. Lumbar spine scans included L1 through L4. Positive changes from baseline indicate improvement in bone health. |
| Secondary | Percent Change From Baseline in Total Hip BMD at Month 12 | Baseline, Month 12 | Total hip BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health. |
| Secondary | Percent Change From Baseline in Femoral Neck BMD at Month 12 | Baseline, Month 12 | Femoral neck BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health. |
| Secondary | Percent Change From Baseline in Lumbar Spine BMD at Month 6 | Baseline, Month 6 | Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory. Lumbar spine scans included L1 through L4. Positive changes from baseline indicate improvement in bone health. |
| Secondary | Percent Change in Total Hip BMD From Baseline at Month 6 | Baseline, Month 6 | Total hip BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health. |
| Secondary | Percent Change From Baseline in Femoral Neck BMD at Month 6 | Baseline, Month 6 | Femoral neck BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health. |
| Secondary | Percent Change From Baseline in Ultra-Distal Radius BMD at Month 12 | Baseline, Month 12 | Ultra-distal radius BMD was assessed by DXA scans. Positive changes from baseline indicate improvement in bone health. |
| Secondary | Percent Change From Baseline in Distal One-third Radius BMD at Month 12 | Baseline, Month 12 | Distal one-third radius BMD was assessed by DXA scans. Positive changes from baseline indicate improvement in bone health. |
| Secondary | Percent Change From Baseline in Serum Procollagen Type I N-terminal Propeptide (s-PINP) at Month 12 | Baseline, Month 12 | Blood samples were taken to measure s-PINP, a bone formation marker. s-PINP concentrations reflect the rate of skeletal new bone formation. Increases in s-PINP indicate anabolic biologic response in the bone. |
| Secondary | Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) at Month 12 | Baseline, Month 12 | Blood samples were taken to measure s-CTX. Elevated levels of s-CTX indicate increased bone resorption (bone loss). |
| Secondary | Number of Participants With New Clinical Fractures | Baseline through Month 12 | Radiological evaluations were performed to identify any new clinical fractures (occurring after the screening visit). |
| Secondary | Percent of Participants With Change in Disease Status | Baseline through Month 12 | The percentage of participants converting from the categories of osteoporosis to osteopenia or from osteopenia to normal at End of Treatment (Month 12) was assessed. Osteoporosis was defined as lumbar spine or total hip BMD T-score ≤ -2.5. Osteopenia was defined as one of the following: * Lumbar spine \> -2.5 and total hip BMD T-score \> -2.5 and \< -1.0 * Lumbar spine \> -2.5 and \< -1.0 and total hip BMD T-score \> -2.5 * Normal was defined as lumbar spine and total hip BMD T-score ≥ -1.0. |
| Secondary | Percent of Participants Experiencing BMD Gains From Baseline of > 0%, > 3%, and > 6% at the Lumbar Spine, Femoral Neck, and Total Hip | Month 12 | Lumbar spine, femoral neck, and total hip BMD were assessed by DXA scans evaluated by a central imaging laboratory. |
| Secondary | Percent Change From Baseline in Total Hip Volumetric BMD as Measured by Quantitative Computed Tomography (QCT) at Month 12 | Baseline, Month 12 | QCT scans were evaluated by a central imaging laboratory. |
| Secondary | Percent Change From Baseline in Femoral Neck Volumetric BMD as Measured by QCT at Month 12 | Baseline, Month 12 | QCT scans were evaluated by a central imaging laboratory. |
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.
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