Trial · NCT05125809
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 | Phase 2: Percent Change in Serum Amino-terminal Propeptide of Type 1 Procollagen (P1NP) from Baseline at Month 1 | Baseline, Month 1 | |
| Primary | Phase 3: Annualized Rate of All Radiographically-Confirmed Fractures, Excluding Morphometric Vertebral Fractures and Fractures of the Fingers, Toes, Face, and Skull at the Primary Analysis | Up to Month 24 | |
| Secondary | Phase 2: Serum Setrusumab Concentration | From Predose up to Month 24 | |
| Secondary | Phase 2: Baseline-Corrected Area Under the Effect Curve (AUEC) for Serum P1NP Over a 1 and 2-Month Period | Baseline, Up to Month 2 | |
| Secondary | Phase 2: Percent Change from Baseline Over Time in Bone Turnover Marker: P1NP | Baseline, Up to Month 24 | |
| Secondary | Phase 2: Percent Change from Baseline Over Time in Bone Turnover Marker: Osteocalcin (OCN) | Baseline, Up to Month 24 | |
| Secondary | Phase 2: Change from Baseline in Dual Energy X-ray (DXA) Lumbar Spine Bone Mineral Density (BMD) Z-score Over Time | Baseline, Up to Month 24 | |
| Secondary | Phase 2: Percent Change from Baseline in DXA Lumbar Spine BMD Over Time | Baseline, Up to Month 24 | |
| Secondary | Phase 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | Up to Month 24 | |
| Secondary | Phase 2: Number of Participants With Anti-Setrusumab Binding and Neutralizing Antibodies | Up to Month 24 | |
| Secondary | Phase 3: Annualized Rate of All Radiographically-Confirmed Fractures, Excluding Morphometric Vertebral Fractures, but Including Fractures of the Fingers, Toes, Face and Skull at the Primary Analysis | Up to Month 24 | |
| Secondary | Phase 3: Annualized Rate of All Radiographically-Confirmed Fractures at the Primary Analysis | Up to Month 24 | |
| Secondary | Phase 3: Change from Baseline in DXA Lumbar Spine BMD Z-score at the Primary Analysis | Baseline, up to Month 24 | |
| Secondary | Phase 3: Change from Baseline in Pediatric Orthopedic Society of North America Pediatric Outcomes Data Collection Instrument (POSNA-PODCI) Sports/Physical Functioning Subscale Score for Pediatric Participants at the Primary Analysis | Baseline, up to Month 24 | |
| Secondary | Phase 3: Proportion of Participants Experiencing New Radiographically Confirmed Fractures, Excluding Morphometric Vertebral Fractures and Fractures of the Fingers, Toes, Face, and Skull at the Primary Analysis | Up to Month 24 | |
| Secondary | Phase 3: Change from Baseline in POSNA-PODCI Pain/Comfort Subscale Score for Pediatric Participants at the Primary Analysis | Baseline, Up to Month 24 | |
| Secondary | Phase 3: Change from Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain Scale for Adult Participants at the Primary Analysis | Baseline, Up to Month 24 | |
| Secondary | Phase 3: Change from Baseline in SF-36 Bodily Pain (BP) Domain Scale for Adult Participants at the Primary Analysis | Baseline, Up to Month 24 | |
| Secondary | Phase 3: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | Up to Month 24 | |
| Secondary | Phase 3: Number of Participants With Anti-Setrusumab Binding and Neutralizing Antibodies | Up to Month 24 |
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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GET https://conductscience.org/api/trials/v1/NCT05125809/registered