An Open-label, Randomized, Active-Controlled, Phase 3 Study of Setrusumab Compared With Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta Types I, III or IV
Status: Active_not_recruiting
Location: See all (20) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The primary objective of the study is to evaluate the effect of setrusumab vs intravenous bisphosphonates (IV-BP) on reduction in fracture rate, including morphometric vertebral fractures in pediatric participants.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 6
Healthy Volunteers: f
View:
• Male or female 2 to \< 7 years of age at time of informed consent
• Clinical diagnosis of OI Types I, III, or IV confirmed by identification of genetic mutation in COL1A1 or COL1A2
• History of ≥ 1 fracture in the past 12 months, ≥ 2 fractures in the past 24 months, or ≥ 1 femur, tibia, or humerus fracture in the past 24 months
• Any prior exposure to, or currently receiving, IV-bisphosphonate therapy for treatment of OI
• Serum 25-hydroxyvitamin D level ≥ 20 ng/mL at the Screening visit. If 25-hydroxyvitamin D levels are below 20 ng/mL, the subject may be rescreened after a minimum of 14 days of vitamin D supplementation as directed by the Investigator
Locations
United States
Arizona
Phoenix Children's Hospital
Phoenix
California
Childrens Hospital LA
Los Angeles
Colorado
Children's Hospital Colorado
Aurora
Connecticut
Yale New Haven Hospital
New Haven
Washington, D.c.
Children's National Hospital DC
Washington D.c.
Delaware
Nemours/ Alfred i. duPoint Hospital for Children
Wilmington
Florida
University of South Florida
Tampa
Illinois
Shriners Hospitals for Children Chicago
Chicago
Missouri
Washington University School of Medicine
St Louis
North Carolina
University of North Carolina at Chapel Hill (UNC)
Chapel Hill
Tennessee
Vanderbilt University Medical Center (VUMC)
Nashville
Texas
Cook Children's Medical Center
Fort Worth
Baylor College of Medicine
Houston
Other Locations
Brazil
Hospital de Clinicas de Porto Alegre (HCPA)
Porto Alegre
Canada
Children's Hospital at London Health Sciences Centre
London
Childrens Hospital Of Eastern Ontario Research Institute, University Of Ottawa
Ottawa
France
Institut Imagine
Paris
Italy
Azienda Ospedaliera Universitaria Policlinico Umberto I
Roma
Netherlands
Universitair Medisch Centrum Utrecht (UMCU) - Wilhelmina Kinderziekenhuis
Utrecht
Poland
Uniwersytet Medyczny w Lodzi - Klinika Endokrynologii i Chorob Metabolicznych
Participants on IV-BP will continue their existing dose/regimen per investigator discretion; for participants not on IV-BP, the dose/regimen will be determined by the investigator.~After the active-controlled period, participants will receive Setrusumab during the extension period
Experimental: Setrusumab
Participants will receive Setrusumab during the active-controlled and extension period