Institutional Review Board, Hospital for Special Surgery
June 13, 2014
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.
Marjolein van der Meulen, PhD
Jeri W. Nieves, PhD
Felicia Cosman, MD
Alana Serota, MD, CCFP, CCD
Dean G. Lorich, MD
David L. Helfet, MD
Douglas N. Mintz, MD
This is a study enrolling 100 patients on long-term bisphosphonate treatment. The whole bone geometry as well as cortical structure along the length of the diaphysis will be analyzed through plain radiographs and CT imaging. Femoral structure of individuals who have experienced atypical femur fracture will be compared to patients of similar demographic and osteoporosis management who have not experienced such fractures. Any differences in femoral geometry between groups in this study will be significant as there are currently no predictors available for likelihood of AFF. This study aims to elucidate the pathophysiology of atypical femur fractures and identify risk factors based on structural geometry of the femur. This may allow inference of an appropriate duration of treatment of bisphosphonates, minimizing likelihood of these debilitating fractures, as well as identification of "susceptible" patients early on and alter decision to start, change, or discontinue BP therapy.
These groups have limitations in that we will only include AFFs in BP-treated individuals, and our focus is on females only. The low incidence of these fractures in the general population requires focusing on AFF and setting the inclusion window at 2 years. Second, women are at greater risk of AFF so we will not study AFFs in men.
Note: Use of teriparatide (Forteo) will be recorded for dates used and duration.