Pediatric safety follow-up after romosozumab treatment for osteogenesis imperfecta

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional follow-up tracks participants with osteogenesis imperfecta who were randomized to the romosozumab arm and completed Trial 20200105 through the Month 15 visit. The primary focus is on post‑treatment safety monitoring after prior exposure to romosozumab, with protocol‑specified visits to collect adverse events and safety laboratory data. The protocol includes provision or monitoring of standard bone‑health supplements such as vitamin D and calcium. Enrollment is limited to those who completed the prior trial and meet local consent/assent requirements, and participants currently in other investigational trials or who recently finished other investigational trials are excluded.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Amgen Call Center
• Email: medinfo@amgen.com
• Phone: 866-572-6436

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Heart structure and function in children and adults with Osteogenesis Imperfecta

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• Romosozumab and denosumab alone or together for postmenopausal osteoporosis

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.