Pediatric safety follow-up after romosozumab treatment for osteogenesis imperfecta
Multicenter, Safety Follow-up Study to Assess Safety of Prior Treatment With Romosozumab in Children and Adolescents With Osteogenesis Imperfecta
This follow-up tests the safety of romosozumab in children and adolescents with osteogenesis imperfecta who previously received romosozumab in an earlier trial.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 71 (estimated) |
| Ages | 5 Years to 19 Years |
| Sex | All |
| Sponsor | Amgen Industry-sponsored |
| Drugs / interventions | romosozumab |
| Locations | 4 sites (Indianapolis, Indiana and 3 other locations) |
| Trial ID | NCT07366086 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are pediatric participants who were randomized to the romosozumab arm in Trial 20200105 and completed that trial through the Month 15 visit, with appropriate consent or assent.
Not a fit: Patients who never received romosozumab in the prior trial, who are currently enrolled in another investigational study, or who finished another investigational trial less than two years ago are unlikely to qualify or benefit from this follow-up.
Why it matters
Potential benefit: If the follow-up confirms an acceptable safety profile, it could support continued or expanded use of romosozumab in children with osteogenesis imperfecta and inform long‑term care decisions.
How similar studies have performed: Romosozumab has shown bone‑building benefits and a characterized safety profile in adults with osteoporosis, but pediatric use for osteogenesis imperfecta is novel and published pediatric data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Indianapolis, Indiana and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.