Trial · NCT03118570
Outcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Radial Trabecular Volumetric Bone Mineral Density (Tr vBMD) at Month 12 | Baseline, Month 12 (end of treatment [EOT]) | Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment (per protocol almost all efficacy endpoints were to be analyzed only in the blinded treatment arms). Participants with an assessment at given time point. | ratio | NUMBER |
| PRIMARY | Change From Baseline in Radial Bone Strength (Failure Load) at Month 12 | Baseline, Month 12 (EOT) | Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment. Participants with an assessment at given time point. | newton (N) | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Radial Bone Strength (Stiffness) at Month 12 | Baseline, Month 12 (EOT) | Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment. Participants with an assessment at given time point. | N/mm | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Radial and Tibial Tr VBMD Over Time: Full Analysis Set | Baseline, Months 6, 12 (EOT), 18, 24 | Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment. Participants with an assessment at given time point. | ratio | NUMBER |
| SECONDARY | Changes From Baseline in Radial and Tibial Tr VBMD at Months 6 and 12: Open-Label Arm | Baseline, Months 6, 12 (EOT) | All participants in the open-label arm who took at least 1 dose of study treatment. Participants with an assessment at given time point. | ratio | NUMBER |
| SECONDARY | Changes From Baseline in Radial and Tibial Bone Strength (Failure Load) Over Time: Full Analysis Set | Baseline, Months 6, 12 (EOT), 18, 24 | Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment. Participants with an assessment at given time point. | N | LEAST_SQUARES_MEAN |
| SECONDARY | Changes From Baseline in Radial and Tibial Bone Strength (Failure Load) at Months 6 and 12: Open-Label Arm | Baseline, Months 6, 12 (EOT) | All participants in the open-label arm who took at least 1 dose of study treatment. Participants with an assessment at given time point. | N | LEAST_SQUARES_MEAN |
| SECONDARY | Changes From Baseline in Radial and Tibial Bone Strength (Stiffness) Over Time: Full Analysis Set | Baseline, Months 6, 12 (EOT), 18, 24 | Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment. Participants with an assessment at given time point. | N/mm | LEAST_SQUARES_MEAN |
| SECONDARY | Changes From Baseline in Radial and Tibial Bone Strength (Stiffness) at Months 6 and 12: Open-Label Arm | Baseline, Months 6, 12 (EOT) | All participants in the open-label arm who took at least 1 dose of study treatment. Participants with an assessment at given time point. | N/mm | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With at Least 1 New Fracture (Peripheral, Vertebral, Long-Bone, Any) at Month 12 | Month 12 (EOT) | Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Lumbar, Total Body, and Femoral Neck Bone Mineral Density (BMD) T-score at Month 6 | Baseline, Month 6 | Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment. Participants with an assessment at given timepoint. | T-score | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Lumbar, Total Body, and Femoral Neck BMD at Month 6 | Baseline, Month 6 | Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment. Participants with an assessment at given timepoint. | g/cm^2 | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Lumbar, Total Body, and Femoral Neck BMD T-score at Month 12 | Baseline, Month 12 (EOT) | Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment. Participants with an assessment at given timepoint. | T-score | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Lumbar, Total Body, and Femoral Neck BMD at Month 12 | Baseline, Month 12 (EOT) | Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment. Participants with an assessment at given timepoint. | g/cm^2 | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Total vBMD (Radial and Tibial) Over Time | Baseline, Months 6, 12 (EOT), 18, and 24 | Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment. Participants with an assessment at given timepoint. | ratio | NUMBER |
| SECONDARY | Change From Baseline in Cortical vBMD (Radial and Tibial) Over Time | Baseline, Months 6, 12 (EOT), 18, and 24 | Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment. Participants with an assessment at given timepoint. | ratio | NUMBER |
| SECONDARY | Number of Participants With Clinically Significant Changes From Baseline in Body Height, Weight and Body Mass Index (BMI) at 6 and 12 Months: Full Analysis Set | Baseline, Month 6, Month 12 (EOT) | Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Lean and Fat Body Mass From Whole Body at Months 6 and 12 | Baseline, Months 6, 12 (EOT) | Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment. Participants with an assessment at given timepoint. | grams | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Amino-Terminal Propeptide of Type 1 Procollagen (P1NP) up to Month 12 | Baseline, Months 1, 3, 6, 9, 12 (EOT) | Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment. Participants with an assessment at given timepoint. | µg/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Carboxy-Terminal Telo-Peptide [CTX-1] up to Month 12 | Baseline, Months 1, 3, 6, 9, 12 (EOT) | Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment. Participants with an assessment at given timepoint. | µg/L | LEAST_SQUARES_MEAN |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03118570/outcomes