Institutional Review Board, Hospital for Special Surgery
June 13, 2014
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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.