Status:
RECRUITING
Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta
Lead Sponsor:
Amgen
Conditions:
Osteogenesis Imperfecta
Eligibility:
All Genders
5-17 years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 25 2027
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT05972551
Start Date
April 22 2024
End Date
August 25 2027
Last Update
December 12 2025
Active Locations (56)
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1
Childrens Hospital of Alabama
Birmingham, Alabama, United States, 35233
2
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016
3
University of California, Los Angeles Interventional Clinical Trials
Los Angeles, California, United States, 90095
4
Nemours Hospital for Children
Wilmington, Delaware, United States, 19803