A Randomized Double Blind Placebo Controlled Multi-Center Parallel Group Study of One Year Duration Followed by Two Years of open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate
IRB Number: 25039
March 07, 2006
Institutional Review Board, Hospital for Special Surgery
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Principal Investigator
Co-Investigators
- Joseph M. Lane, MD
- Helene Pavlov, MD, FACR
- Peter Bullough, MD
- Erin Carter, MS
Summary
The primary objective of this study of patients with Osteogenesis Imperfecta (OI) is to determine the effectiveness of Risedronate, a bisphosphonate, in decreasing fracture rate in children >4 to <16 years of age with Osteogenesis Imperfecta (OI).
Approximately 124 patients are to be enrolled across 15-20 study centers located in North America, Europe, and South America. Patients may be enrolled through August of 2006. After being enrolled, the duration of the study and follow-up is three years.
The secondary objectives include safety and tolerability, laboratory profiles, changes from baseline in bone age, and annualized growth velocity from baseline.
Inclusion/Exclusion Criteria
Inclusion Criteria:
- Children >4 to <16 years old diagnosed with mild OI (type I or type IV);
- At least 2 evaluable lumbar spine vertebral bodies (L1-L4 without fracture or degenerative disease);
- If female (post-menarche/sexually active), must agree to use a reliable form of contraceptive during the study and have a negative serum/urine pregnancy test at screening;
- All subjects and parents/legal guardians must be able and willing to provide a valid written informed consent/assent form.
Major Exclusion Criteria:
- History of Bisphosphonate use within 1 year of enrollment (except single-dose oral bisphosphonates, Risedronate or Alendronate)
- Osteoporosis, secondary to diseases other than OI or drug therapies
- Clinically-significant abnormal laboratory results or use of certain drugs/medications
- Participation in another clinical trial within 3 months of enrollment.
Contact Information
Erin M. Carter, MS
Clinical Coordinator/Genetic Counselor
The Kathryn O. and Alan C. Greenberg Center for Skeletal Dysplasias
212.774.7332 or CSD@hss.edu