Actively Recruiting
Safety Follow-up Study to Assess Prior Romosozumab Treatment in Children and Adolescents With Osteogenesis Imperfecta
Led by Amgen · Updated on 2026-05-08
71
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial focuses on children and adolescents with osteogenesis imperfecta (OI) who previously took part in Study 20200105. It aims to evaluate the safety of the drug romosozumab in these participants, regardless of whether they completed the full treatment or stopped early. The study is a follow-up to monitor safety outcomes after prior exposure to romosozumab. Participants who completed the romosozumab trial will continue their standard care treatment, which includes vitamin D and calcium supplements as advised by their doctors and local guidelines. No new investigational drug will be given during this follow-up study. During the study, researchers will observe participants for adverse events over a period of up to 9 months. Standard care treatments will be managed by the healthcare provider, and participants will be monitored to ensure adherence and safety. The total participation duration aligns with the follow-up period to assess any late effects from the previous treatment.
CONDITIONS
Brief 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 or legal representative has provided informed consent or assent before any trial activities.
- Participant completed the romosozumab trial 20200105 through the Month 15 Visit, whether they finished all doses or stopped early.
You will not qualify if you...
- Currently participating in another investigational drug or device trial, or ended such treatment less than 2 years ago, except for trial 20200105.
- Unlikely to be available for all required trial visits or to follow all study procedures.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 9 months
Participants who completed prior romosozumab treatment are observed while receiving standard of care treatment with calcium and vitamin D as recommended by their healthcare provider.
Visits scheduled according to investigator discretion and local guidance
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
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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