Setrusumab vs Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta
Public ClinicalTrials.gov record NCT05768854. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-label, Randomized, Active-Controlled, Phase 3 Study of Setrusumab Compared With Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta Types I, III or IV
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of the study is to evaluate the effect of setrusumab vs intravenous bisphosphonates (IV-BP) on reduction in fracture rate, including morphometric vertebral fractures in pediatric participants.
Study identification
- NCT ID
- NCT05768854
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 69 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 6 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 14, 2023 (Actual)
- Primary completion
- Oct 23, 2025 (Actual)
- Completion
- Apr 2027 (Estimated)
- Last update posted
- Oct 20, 2026
2023 – 2027
United States locations
- U.S. sites
- 13
- U.S. states
- 12
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85206 | — |
| Childrens Hospital LA | Los Angeles | California | 90027 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | — |
| Nemours/ Alfred i. duPoint Hospital for Children | Wilmington | Delaware | 19803 | — |
| Children's National Hospital DC | Washington D.C. | District of Columbia | 20010 | — |
| University of South Florida | Tampa | Florida | 33612 | — |
| Shriners Hospitals for Children Chicago | Chicago | Illinois | 60707 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| University of North Carolina at Chapel Hill (UNC) | Chapel Hill | North Carolina | 27599 | — |
| Vanderbilt University Medical Center (VUMC) | Nashville | Tennessee | 37212 | — |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05768854, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 20, 2026 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05768854 live on ClinicalTrials.gov.