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Pediatric Safety Follow-up Study of Prior Treatment With Romosozumab for Osteogenesis Imperfecta
Sponsor: Amgen
Summary
The primary objective of this trial is to evaluate the safety of romosozumab in participants with osteogenesis imperfecta (OI) that have completed Study 20200105, regardless of whether they received investigational product (romosozumab) until the last protocol-specified dose or ended investigational product early.
Official title: Multicenter, Safety Follow-up Study to Assess Safety of Prior Treatment With Romosozumab in Children and Adolescents With Osteogenesis Imperfecta
Key Details
Gender
All
Age Range
5 Years - 19 Years
Study Type
INTERVENTIONAL
Enrollment
71
Start Date
2026-03-18
Completion Date
2028-05-21
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
Vitamin D
Participants are recommended to receive Vitamin D supplements as standard of care treatment, per investigator discretion and local guidance.
Calcium
Participants are recommended to receive Calcium supplements as standard of care treatment, per investigator discretion and local guidance.
Locations (2)
Indiana University
Indianapolis, Indiana, United States
Universitaetsklinikum Wuerzburg
Würzburg, Germany