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

Recruiting now · Phase 3

Conditions studied: Osteogenesis Imperfecta

In brief

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.

Key facts

Study ID

NCT07366086

Run by

Amgen

People needed

71

Starts

2026-03-18

Expected to finish

2028-04-19

Last updated by the study team

2026-06-22

Who can join

Age: 5 and older, up to 19. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant has provided informed consent/assent prior to initiation of any trial 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 trial-specific activities/procedures being initiated.
• Participant was randomized to the romosozumab arm and completed Trial 20200105 through the Month 15 Visit, regardless of whether they received investigational product (romosozumab) until the last protocol-specified dose or ended investigational product early.

You may not qualify if…

• Currently receiving treatment in another investigational device or drug trial, or less than 2 years since ending treatment on another investigational device or drug trial(ies) with the exception of trial 20200105. Other investigational procedures while participating in this trial are excluded.
• Participant likely to not be available to complete all protocol-required trial visits or procedures, and/or to comply with all required trial procedures to the best of the participant and investigator's knowledge.

Where it is running

• Indiana University — Indianapolis, Indiana, United States (enrolling)
• Universitaetsklinikum Koeln — Cologne, Germany (enrolling)
• Universitaetsklinikum Wuerzburg — Würzburg, Germany (enrolling)
• Okayama Saiseikai Outpatient Center Hospital — Okayama, Okayama-ken, Japan (enrolling)

Full record on ClinicalTrials.gov

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