Pediatric Safety Follow-up Study of Prior Treatment With Romosozumab for Osteogenesis Imperfecta
ConditionOsteogenesis Imperfecta
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age5-19
SponsorAmgen
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Vitamin D
Dietary supplementParticipants are recommended to receive Vitamin D supplements as standard of care treatment, per investigator discretion and local guidance.
Calcium
Dietary supplementParticipants are recommended to receive Calcium supplements as standard of care treatment, per investigator discretion and local guidance.
Treatment groups
71 Participants
are divided into 1 treatment groupGroup A: Standard of CareOther 2 interventions
Trial outcomes
Primary outcomes
1
Number of Participants with Adverse Events (AEs)
Time frame
Up to 9 months Source ClinicalTrials.gov