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Recruiting
Sponsor ID
20220043

Pediatric Safety Follow-up Study of Prior Treatment with Romosozumab for Osteogenesis Imperfecta

Sponsor ID
20220043
Clinicaltrials.gov ID
NCT07366086
EUCTIS ID
2023-503293-21-00
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 3
Product
romosozumab
Type
Interventional
Masking
None (Open Label)
Enrollment
71
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of Participants with Adverse Events (AEs)

Timeframe: Up to 9 months

Secondary Outcome Measures
Not Available

Locations

Location
Status
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Location
Indiana University
Indianapolis, IN, United States, 46202
Status
Recruiting
Location
Universitaetsklinikum Wuerzburg
Wuerzburg, Germany, 97074
Status
Recruiting
Location
Universitaetsklinikum Koeln
Koeln, Germany, 50937
Status
Recruiting
Location
Okayama Saiseikai Outpatient Center Hospital
Okayama-shi, Okayama, Japan, 700-0013
Status
Recruiting
Study Info
Age
5 - 19 Years
Condition
  • Osteogenesis Imperfecta
    • Sex
    All
    Trial Dates
    Mar 2026 - Apr 2028
    Inclusion and 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.