๐Ÿ›๏ธ Verified NIH Record โ€ข 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

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Ultragenyx Pharmaceutical Inc

๐Ÿฉบ 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

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ 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,

๐Ÿ’ฐ 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.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—