Pediatric Safety Follow-up Study of Prior Treatment With Romosozumab for Osteogenesis Imperfecta
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vitamin D, Calcium.
- Who it may be relevant to
- Registry conditions: Osteogenesis Imperfecta. Basic parameters: 5 years — 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Germany, Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Multicenter, Safety Follow-up Study to Assess Safety of Prior Treatment With Romosozumab in Children and Adolescents With Osteogenesis Imperfecta
Overview
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.
Interventions
- Dietary supplement Vitamin D
Participants are recommended to receive Vitamin D supplements as standard of care treatment, per investigator discretion and local guidance. - Dietary supplement Calcium
Participants are recommended to receive Calcium supplements as standard of care treatment, per investigator discretion and local guidance.
Primary outcome measures
- Number of Participants with Adverse Events (AEs) [Time frame: Up to 9 months]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Germany · 2 centers
- Universitaetsklinikum Koeln — Cologne
- Universitaetsklinikum Wuerzburg — Würzburg
United States · 1 center
- Indiana University — Indianapolis
Japan · 1 center
- Okayama Saiseikai Outpatient Center Hospital — Okayama
Identifiers
NCT: NCT07366086 · 20220043 · 2023-503293-21-00