NCT07366086PHASE3Recruiting
Pediatric Safety Follow-up Study of Prior Treatment With Romosozumab for Osteogenesis Imperfecta
Amgen
Start Date
3/18/2026
Completion Date
4/19/2028
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.
Eligibility Criteria
Age Range: 5 years to 19 years
Inclusion Criteria:
\- 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.
Exclusion Criteria:
* 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.
Interventions
DIETARY_SUPPLEMENT
Vitamin D
DIETARY_SUPPLEMENT
Calcium
Conditions
Osteogenesis Imperfecta
Locations
Indiana University
Indianapolis, Indiana 46202
United States
Universitaetsklinikum Koeln
Cologne, 50937
Germany
Universitaetsklinikum Wuerzburg
Würzburg, 97074
Germany
Okayama Saiseikai Outpatient Center Hospital
Okayama, Okayama-ken 700-0013
Japan