Actively Recruiting
Pediatric Safety Follow-up Study of Prior Treatment With Romosozumab for Osteogenesis Imperfecta
Led by Amgen · Updated on 2026-05-08
71
Participants Needed
4
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Pediatric Safety Follow-up Study of Prior Treatment With Romosozumab for Osteogenesis Imperfecta
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant has provided informed consent/assent prior to trial activities, or legally authorized representative has provided consent with participant assent as per local regulations
- Participant was randomized to the romosozumab arm and completed Trial 20200105 through the Month 15 Visit, regardless of whether they received all protocol-specified doses or ended treatment early
You will not qualify if you...
- Currently receiving treatment in another investigational device or drug trial, or less than 2 years since ending treatment on other investigational trials except Trial 20200105
- Participant likely to be unavailable to complete all protocol-required visits or comply with required trial procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
2
Universitaetsklinikum Koeln
Cologne, Germany, 50937
Actively Recruiting
3
Universitaetsklinikum Wuerzburg
Würzburg, Germany, 97074
Actively Recruiting
4
Okayama Saiseikai Outpatient Center Hospital
Okayama, Okayama-ken, Japan, 700-0013
Actively Recruiting
Research Team
A
Amgen Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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