Bisphosphonate Therapy and Atypical Fractures: Update

The FDA recently issued a Drug Safety Communication regarding oral bisphosphonates and atypical subtrochanteric femur fractures. The FDA and an ASBMR task force continue to review this issue.

On March 24, the New England Journal of Medicine (NEJM) published a paper entitled “Bisphosphonates and Fractures of the Subtrochanteric or Diaphyseal Femur” by Dennis M. Black, Ph.D and colleagues, which reported on secondary analyses of the results of three large, randomized bisphosphonate trials. The paper concludes that fractures of the subtrochanteric or diaphyseal femur are exceeding rare, even among women treated with bisphosphonates for as long as 10 years. An editorial by Elizabeth M. Shane, M.D., former ASBMR president and co-chair of the ASBMR task force on Subtrochanteric fractures accompanies the paper by Black and colleagues in NEJM.

Both the FDA Drug Safety Communication, the NEJM paper, and Dr. Shane's editorial make reference to recent papers from the JBMR. As a service to researchers, physicians, patients, and others concerned with this important issue, ASBMR is making the full text of these four papers freely available through the JBMR web site:

Abrahamsen B, Eiken P, Eastell R. Subtrochanteric and diaphyseal femur fractures in patients treated with alendronate: a register-based national cohort study. J Bone Miner Res. 2009;24:1095-1102. [Free Full Text]

Glover SJ, Gall M, Schoenborn-Kellenberger O, et al. Establishing a reference interval for bone turnover markers in 637 healthy, young, premenopausal women from the United Kingdom, France, Belgium, and the United States. J Bone Miner Res 2009;24:389-397. [Free Full Text]

Somford MP, Draijer FW, Thomassen BJ, Chavassieux PM, Boivin G, Papapoulos SE. Bilateral fractures of the femur diaphysis in a patient with rheumatoid arthritis on long-term treatment with alendronate: clues to the mechanism of increased bone fragility. J Bone Miner Res. 2009;24:1736-1740. [Free Full Text]

Schwartz AV, Bauer DC, Cummings SR, et al. Efficacy of continued alendronate for fractures in women with and without prevalent vertebral fracture: the FLEX trial. J Bone Miner Res 2010. January 8 (Epub ahead of print). [Free Full Text]

For additional information on this issue, see the ASBMR press release on Bisphosphonate Therapy and Atypical Fractures and the FDA’s Drug Safety Communication.