Vitamin D: Participants are recommended to receive Vitamin D supplements as standard of care treatment, per investigator discretion and local guidance.
Calcium: Participants are recommended to receive Calcium supplements as standard of care treatment, per investigator discretion and local guidance.
Study summary
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.
Eligibility
Sex
ALL
Min age
5 Years
Max age
19 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Number of Participants with Adverse Events (AEs) — Up to 9 months
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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