Trial · NCT03512262
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Lumbar Spine BMD at Month 12 | Baseline, Month 12 | Intent-to-Treat (ITT) Population: All participants randomized into the study. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Total Hip BMD at Month 12 | Baseline, Month 12 | ITT Population: All participants randomized into the study. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Femoral Neck BMD at Month 12 | Baseline, Month 12 | ITT Population: All participants randomized into the study. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Lumbar Spine BMD at Month 6 | Baseline, Month 6 | ITT Population: All participants randomized into the study. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change in Total Hip BMD From Baseline at Month 6 | Baseline, Month 6 | ITT Population: All participants randomized into the study. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Femoral Neck BMD at Month 6 | Baseline, Month 6 | ITT Population: All participants randomized into the study. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Ultra-Distal Radius BMD at Month 12 | Baseline, Month 12 | ITT Population: All participants randomized into the study. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Distal One-third Radius BMD at Month 12 | Baseline, Month 12 | ITT Population: All participants randomized into the study. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Serum Procollagen Type I N-terminal Propeptide (s-PINP) at Month 12 | Baseline, Month 12 | ITT Population: All participants randomized into the study. Here, overall number of participants analyzed is the total number of participants who had s-PINP evaluation at Baseline and Month 12. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) at Month 12 | Baseline, Month 12 | ITT Population: All participants randomized into the study. Here, overall number of participants analyzed is the total number of participants who had s-CTX evaluation at Baseline and Month 12. | percent change | MEAN |
| SECONDARY | Number of Participants With New Clinical Fractures | Baseline through Month 12 | ITT Population: All participants randomized into the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent of Participants With Change in Disease Status | Baseline through Month 12 | ITT Population: All participants randomized into the study. Here, overall number of participants analyzed is the total number of participants who had baseline evaluation and also had end of treatment BMD disease category evaluation (normal, osteopenia, and osteoporosis).~. | percentage of participants | NUMBER |
| 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 | ITT Population: All participants randomized into the study. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Total Hip Volumetric BMD as Measured by Quantitative Computed Tomography (QCT) at Month 12 | Baseline, Month 12 | Only 2 participants per reporting group had volumetric BMD measured by QCT at baseline and Month 12, therefore, no data is reported here to maintain participant confidentiality. | ||
| SECONDARY | Percent Change From Baseline in Femoral Neck Volumetric BMD as Measured by QCT at Month 12 | Baseline, Month 12 | Only 2 participants per reporting group had volumetric BMD measured by QCT at baseline and Month 12, therefore, no data is reported here to maintain participant confidentiality. |
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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