NCT07366086

Pediatric Safety Follow-up Study of Prior Treatment With Romosozumab for Osteogenesis Imperfecta

Multicenter, Safety Follow-up Study to Assess Safety of Prior Treatment With Romosozumab in Children and Adolescents With Osteogenesis Imperfecta

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 71 (estimated)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 5 Years – 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteogenesis Imperfecta

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin D	Participants are recommended to receive Vitamin D supplements as standard of care treatment, per investigator discretion and local guidance.
DIETARY_SUPPLEMENT	Calcium	Participants are recommended to receive Calcium supplements as standard of care treatment, per investigator discretion and local guidance.

Timeline

• Start date: 2026-03-18
• Primary completion: 2028-05-21
• Completion: 2028-05-21
• First posted: 2026-01-26
• Last updated: 2026-03-31

Locations

2 sites across 2 countries: United States, Germany