Trial · NCT03118570
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Radial Trabecular Volumetric Bone Mineral Density (Tr vBMD) at Month 12 | Baseline, Month 12 (end of treatment [EOT]) | Assessed by high resolution peripheral quantitative computed tomography (HRpQCT). HRpQCT scans were performed on the participant's distal non-dominant arm. In cases of an arm that had been supported with rods or had significant deformity, the dominant limb was selected. Data presents the ratio of the means between the visit and Baseline from analysis of covariance (ANCOVA). |
| Primary | Change From Baseline in Radial Bone Strength (Failure Load) at Month 12 | Baseline, Month 12 (EOT) | Assessed by finite element analysis (FEA) of models generated from HRpQCT images of the distal radius. |
| Primary | Change From Baseline in Radial Bone Strength (Stiffness) at Month 12 | Baseline, Month 12 (EOT) | Assessed by FEA of models generated from HRpQCT images of the distal radius. |
| Secondary | Change From Baseline in Radial and Tibial Tr VBMD Over Time: Full Analysis Set | Baseline, Months 6, 12 (EOT), 18, 24 | Assessed by HRpQCT. HRpQCT scans were performed on the participant's distal non-dominant arm. In cases of an arm that had been supported with rods or had significant deformity, the dominant limb was selected. Data presented is the ratio of the means between the Visit and Baseline from ANCOVA. |
| Secondary | Changes From Baseline in Radial and Tibial Tr VBMD at Months 6 and 12: Open-Label Arm | Baseline, Months 6, 12 (EOT) | Assessed by HRpQCT. HRpQCT scans were performed on the participant's distal non-dominant arm. In cases of an arm that had been supported with rods or had significant deformity, the dominant limb was selected. Data presented is the ratio of the means between the Visit and Baseline from ANCOVA. |
| Secondary | Changes From Baseline in Radial and Tibial Bone Strength (Failure Load) Over Time: Full Analysis Set | Baseline, Months 6, 12 (EOT), 18, 24 | Assessed by FEA of models generated from HRpQCT images of the distal radius. |
| 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) | Assessed by FEA of models generated from HRpQCT images of the distal radius. |
| Secondary | Changes From Baseline in Radial and Tibial Bone Strength (Stiffness) Over Time: Full Analysis Set | Baseline, Months 6, 12 (EOT), 18, 24 | Assessed by FEA of models generated from HRpQCT images of the distal radius. |
| Secondary | Changes From Baseline in Radial and Tibial Bone Strength (Stiffness) at Months 6 and 12: Open-Label Arm | Baseline, Months 6, 12 (EOT) | Assessed by FEA of models generated from HRpQCT images of the distal radius. |
| Secondary | Percentage of Participants With at Least 1 New Fracture (Peripheral, Vertebral, Long-Bone, Any) at Month 12 | Month 12 (EOT) | Fracture assessment, confirmed by central radiographic reading, was carried out for peripheral including all major long bones, minor bone (digits, ribs) and vertebral fractures. Fractures without clinical symptoms, detected only by means of radiographic investigations, were not included in the analysis. |
| Secondary | Change From Baseline in Lumbar, Total Body, and Femoral Neck Bone Mineral Density (BMD) T-score at Month 6 | Baseline, Month 6 | BMD was evaluated by dual-energy x-ray absorptiometry (DXA). T-Score was calculated based on actual measured bone density value. T-scores are standardized scores that reflect the standard deviations (SDs) above/below the normal mean for young adults. A score of 50 indicates the population mean with a standard deviation of 10. A positive change in DXA T-score indicates an improvement in BMD. |
| Secondary | Change From Baseline in Lumbar, Total Body, and Femoral Neck BMD at Month 6 | Baseline, Month 6 | BMD was evaluated by DXA. |
| Secondary | Change From Baseline in Lumbar, Total Body, and Femoral Neck BMD T-score at Month 12 | Baseline, Month 12 (EOT) | BMD was evaluated by DXA. T-Score was calculated based on actual measured bone density value. T-scores are standardized scores that reflect the standard deviations (SDs) above/below the normal mean for young adults. A score of 50 indicates the population mean with a standard deviation of 10. A positive change in DXA T-score indicates an improvement in BMD. |
| Secondary | Change From Baseline in Lumbar, Total Body, and Femoral Neck BMD at Month 12 | Baseline, Month 12 (EOT) | BMD was evaluated by DXA. |
| Secondary | Change From Baseline in Total vBMD (Radial and Tibial) Over Time | Baseline, Months 6, 12 (EOT), 18, and 24 | Assessed by HRpQCT. HRpQCT scans were performed on the participant's distal non-dominant arm. In cases of an arm that had been supported with rods or had significant deformity, the dominant limb was selected. Data presented is the ratio of the means between the Visit and Baseline from ANCOVA. |
| Secondary | Change From Baseline in Cortical vBMD (Radial and Tibial) Over Time | Baseline, Months 6, 12 (EOT), 18, and 24 | Assessed by HRpQCT. HRpQCT scans were performed on the participant's distal non-dominant arm. In cases of an arm that had been supported with rods or had significant deformity, the dominant limb was selected. Data presented is the ratio of the means between the Visit and Baseline from ANCOVA. |
| 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) | |
| Secondary | Change From Baseline in Lean and Fat Body Mass From Whole Body at Months 6 and 12 | Baseline, Months 6, 12 (EOT) | Lean and fat body mass was evaluated using whole body DXA (including the head). |
| 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) | |
| Secondary | Change From Baseline in Carboxy-Terminal Telo-Peptide [CTX-1] up to Month 12 | Baseline, Months 1, 3, 6, 9, 12 (EOT) |
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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