Institutional Review Board, Hospital for Special Surgery
March 07, 2006
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
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.
Major Exclusion Criteria:
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