Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta (NCT05972551)
A Phase 3, Open-Label, Multicenter, Randomized Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta
🩺 Plain-English Summary (8th-Grade Level)
The primary objective of this study is to evaluate the effect of romosozumab treatment for 12-months compared with bisphosphonate(s) on the number of clinical fractures at 12-months; the number of any fractures at 12-months and change in lumbar spine bone mineral density (BMD) Z-score at 6-months.
Who can join: Review the eligibility criteria below.
Location: Childrens Hospital of Alabama — Birmingham, Alabama
Age range: 5 Years to 17 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (65 Sites)
Showing the first 25 of 65 sites.
- Childrens Hospital of Alabama — Birmingham, Alabama
- Phoenix Childrens Hospital — Phoenix, Arizona
- University of California, Los Angeles Interventional Clinical Trials — Los Angeles, California
- Nemours Hospital for Children — Wilmington, Delaware
- Nemours Childrens Hospital — Orlando, Florida
- University of South Florida - Carol and Frank Morsani Center for Advanced Health Care — Tampa, Florida
- Emory University — Atlanta, Georgia
- Indiana University — Indianapolis, Indiana
- Kennedy Krieger Institute — Baltimore, Maryland
- Boston Childrens Hospital — Boston, Massachusetts
- Mayo Clinic Childrens Center — Rochester, Minnesota
- Gillette Childrens Hospital and Clinic Saint Paul — Saint Paul, Minnesota
- Vanderbilt University Medical Center — Nashville, Tennessee
- Marshfield Clinic — Marshfield, Wisconsin
- Monash Childrens Hospital — Clayton, Victoria
- Perth Childrens Hospital — Nedlands, Western Australia
- Kepler Universitaetsklinikum GmbH — Linz,
- Universitair Ziekenhuis Leuven - Campus Gasthuisberg — Leuven,
- Childrens Hospital of Eastern Ontario — Ottawa, Ontario
- The Hospital for Sick Children — Toronto, Ontario
- Centre Hospitalier Universitaire Sainte Justine — Montreal, Quebec
- Peking Union Medical College Hospital — Beijing, Beijing Municipality
- The University of Hong Kong-Shenzhen Hospital — Shenzhen, Guangdong
- Tongji Hospital , Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei
- Childrens Hospital of Soochow University — Suzhou, Jiangsu
💰 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 § 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 — Los Angeles, California
- Setrusumab vs Placebo for Osteogenesis Imperfecta — Little Rock, Arkansas
- Cardiopulmonary Outcomes in Osteogenesis Imperfecta: BBD7708 — Los Angeles, California
- Clear Aligners for the Treatment of Dental Malocclusion in OI — Los Angeles, California
- Setrusumab vs Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta — Phoenix, Arizona
Explore by condition: All Osteogenesis Imperfecta clinical trials
💡 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.