Institutional Review Board, Hospital for Special Surgery
May 24, 2007
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 purpose of the Fragile Bone Registry is to gather as much information as we can about patients as possible who have osteopenia, osteoporosis, or a history of a low energy fracture. This will facilitate investigators in developing a better understanding of the clinical features, pathobiology, and genetic links associated with fragile bones. With this increased knowledge, investigators hope to identify the unmet needs of patients with fragile bones and develop new and better treatments to improve disease outcomes and quality of life. Patients will be asked to allow researchers to gather information about their background and medical history, and gather clinical information on them. Approximately 600 patients will be enrolled during the course of this registry. Patients will be followed-up on a yearly basis
Joseph M.Lane, MD
Jin Chen (Research Coordinator)