Status:
COMPLETED
Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children
Lead Sponsor:
Warner Chilcott
Conditions:
Osteogenesis Imperfecta
Eligibility:
All Genders
4-15 years
Phase:
PHASE3
Brief Summary
Children with Osteogenesis Imperfecta (OI) have bone pain, low bone mass and fractures. There are no approved drugs for the treatment of OI in children, even though some intravenous (IV) bisphosphonat...
Eligibility Criteria
Inclusion
- OI diagnosis
- increased risk of fracture: either has a history of at least 1 radiographically confirmed, non-traumatic or low impact fracture plus low bone mineral density (BMD) or has very low BMD with or without a history of fractures.
Exclusion
- Any bisphosphonate use within one year of enrollment
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT00106028
Start Date
November 1 2004
End Date
March 1 2010
Last Update
April 22 2013
Active Locations (20)
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1
Miami Children's Hospital
Miami, Florida, United States, 33155
2
University of Nebraska Medical Center, Children's Hospital
Omaha, Nebraska, United States, 68114
3
Hospital for Special Surgery
New York, New York, United States, 10021
4
Wright State University BioMedical Imaging Laboratory and Miami Valley Hospital
Dayton, Ohio, United States, 45409