Multicenter, Safety Follow-Up Study to Assess Safety of Prior Treatment with Romosozumab in Children and Adolescents with Osteogenesis Imperfecta
Erik Imel, MD
Primary Investigator
Brief description of study
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 will be determined based on sponsor records and our documentation from the parent study. We will not be conducting medical record reviews or utilizing standard recruitment methods, as this is a rollover study with a predefined eligible population.
Detailed description of study
- Dietary Supplement: Vitamin D
- Dietary Supplement: Calcium
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Osteogenesis imperfecta
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Age: 17 years or below
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Gender: All
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.
