Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta

Running, not enrolling · Phase 3

Conditions studied: Osteogenesis Imperfecta

In brief

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.

Key facts

Study ID

NCT05972551

Run by

Amgen

People needed

111

Starts

2024-04-22

Expected to finish

2027-07-30

Last updated by the study team

2026-05-27

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures.
• OR
• Participant's legally authorized representative has provided informed consent when the participant is legally too young to provide informed consent and the participant has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated.
• Ambulatory male and female children and adolescents, age 5 to <18 years, including ambulatory with assistance as defined in the pediatric osteogenesis imperfecta (OI) population.
• Clinical diagnosis of OI, defined as clinical history consistent with type I, III, or IV OI as determined by presence of expected phenotype (examples include: facial shape, voice, blue sclera, dentinogenesis imperfecta, typical radiographic features, fracture pattern) and lack of additional features unrelated to type I, III, or IV OI (eg, blindness, mental retardation, neuropathy, and craniosynostosis).
• o If familial, also must be autosomal dominant.
• Meets at least one of the following:
• 3 or more fractures within the previous 2 years, or
• 1 or more nonvertebral fracture(s) within the previous 2 years and at least 1 prevalent vertebral fracture, or
• 2 or more prevalent vertebral fractures.

You may not qualify if…

• Disease Related
• History of an electrophoresis pattern inconsistent with type I, III or IV OI.
• History of known mutation in a gene other than collagen type I alpha 1/collagen type I alpha 2 (COL1A1/COL1A2) causing OI or other metabolic bone disease.
• History of congenital dislocation of the radial head, interosseous membrane calcification, or exuberant callus formation.

Where it is running

• Phoenix Childrens Hospital — Phoenix, Arizona, United States
• University of California, Los Angeles Interventional Clinical Trials — Los Angeles, California, United States
• Nemours Hospital for Children — Wilmington, Delaware, United States
• Nemours Childrens Hospital — Orlando, Florida, United States
• University of South Florida - Carol and Frank Morsani Center for Advanced Health Care — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Indiana University — Indianapolis, Indiana, United States
• Kennedy Krieger Institute — Baltimore, Maryland, United States
• Boston Childrens Hospital — Boston, Massachusetts, United States
• Mayo Clinic Childrens Center — Rochester, Minnesota, United States
• Gillette Childrens Hospital and Clinic Saint Paul — Saint Paul, Minnesota, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Marshfield Clinic — Marshfield, Wisconsin, United States
• Monash Childrens Hospital — Clayton, Victoria, Australia
• Perth Childrens Hospital — Nedlands, Western Australia, Australia
• Kepler Universitaetsklinikum GmbH — Linz, Austria
• Universitair Ziekenhuis Leuven - Campus Gasthuisberg — Leuven, Belgium
• Childrens Hospital of Eastern Ontario — Ottawa, Ontario, Canada
• The Hospital for Sick Children — Toronto, Ontario, Canada
• Centre Hospitalier Universitaire Sainte Justine — Montreal, Quebec, Canada
• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China
• The University of Hong Kong-Shenzhen Hospital — Shenzhen, Guangdong, China
• Tongji Hospital , Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China
• Childrens Hospital of Soochow University — Suzhou, Jiangsu, China
• Childrens Hospital of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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