๐๏ธ Verified NIH Record โข Updated 2026-02-24
Setrusumab vs Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta (NCT05768854)
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
๐ต Active, Not Recruiting Phase3 ๐ Investigational Drug / Biologic Sponsor: Ultragenyx Pharmaceutical Inc
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Phoenix Children's Hospital โ Phoenix, Arizona
Age range: 2 Years to 6 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (20 Sites)
- Phoenix Children's Hospital โ Phoenix, Arizona
- Childrens Hospital LA โ Los Angeles, California
- Children's Hospital Colorado โ Aurora, Colorado
- Yale New Haven Hospital โ New Haven, Connecticut
- Nemours/ Alfred i. duPoint Hospital for Children โ Wilmington, Delaware
- Children's National Hospital DC โ Washington D.C., District of Columbia
- University of South Florida โ Tampa, Florida
- Shriners Hospitals for Children Chicago โ Chicago, Illinois
- Washington University School of Medicine โ St Louis, Missouri
- University of North Carolina at Chapel Hill (UNC) โ Chapel Hill, North Carolina
- Vanderbilt University Medical Center (VUMC) โ Nashville, Tennessee
- Cook Children's Medical Center โ Fort Worth, Texas
- Baylor College of Medicine โ Houston, Texas
- Hospital de Clinicas de Porto Alegre (HCPA) โ Porto Alegre, Rio Grande do Sul
- Children's Hospital at London Health Sciences Centre โ London, Ontario
- Childrens Hospital Of Eastern Ontario Research Institute, University Of Ottawa โ Ottawa,
- Institut Imagine โ Paris,
- Azienda Ospedaliera Universitaria Policlinico Umberto I โ Roma,
- Universitair Medisch Centrum Utrecht (UMCU) - Wilhelmina Kinderziekenhuis โ Utrecht,
- Uniwersytet Medyczny w Lodzi - Klinika Endokrynologii i Chorob Metabolicznych โ Lodz,
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Osteogenesis Imperfecta
- Dental Malocclusion and Craniofacial Development in OI โ Los Angeles, California
- Setrusumab vs Placebo for Osteogenesis Imperfecta โ Little Rock, Arkansas
- Cardiopulmonary Outcomes in Osteogenesis Imperfecta: BBD7708 โ Los Angeles, California
- Clear Aligners for the Treatment of Dental Malocclusion in OI โ Los Angeles, California
- Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta โ Birmingham, Alabama
Explore by condition: All Osteogenesis Imperfecta clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.