Dr. Shane noted in an interview that “[i]t may well be that this type of fracture is associated with bisphosphonates, but we don't yet know who is vulnerable and we need more information and more research in order to determine that.”
The Hospital for Special Surgery study was supported by a grant from the National Institutes of Health. The Columbia researchers received no compensation for their study. Dr. Shane receives research support from Eli Lilly, Merck, and Novartis. The three-study analysis was supported by Merck and Novartis. The investigators reported financial relationships with Merck and Novartis.
“We don't yet know who is vulnerable” to rare instances of atypical femur fracture, Dr. Elizabeth Shane said.
Source Courtesy Columbia University Medical Center
A typical osteoporotic fracture (left) is contrasted with an atypical subtrochanteric fracture in a patient after many years of bisphosphonate therapy.
Source Images courtesy Dr. Melvin Rosenwasser, Columbia University
My Take
Smoke Signals May Be False Alarm
It's against the law to shout “fire” in a crowded theater (unless there really is a fire).
Recent misleading reports in the lay press of cases of “atypical” femur fractures in patients taking Fosamax, and recent (non–peer reviewed) reports of orthopedic research suggesting a strong link between bisphosphonates and subtrochanteric femur fractures appear to be in that vein.
In a statement, the FDA said, “At this point, the data that FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures.” We have reviewed the data (J. Clin. Endocrinol. Metab. 2010 Feb. 19 [
Because of the small number of cases reported, it is unlikely that a sufficiently large series of such fractures could be assembled to begin to tease out risk factors for the fractures.
Lost in the “smoke” is the serious problem caused by osteoporosis, the deaths and disability associated with fractures and the benefits of alendronate and similar drugs in reducing the risk of fractures. Life is about balancing benefits with risks. For the vast majority of patients with osteoporosis, the benefits of alendronate and other approved treatments for osteoporosis far outweigh the risks.
NELSON B. WATTS, M.D., is an endocrinologist and director of the University of Cincinnati's bone health and osteoporosis center. He disclosed that he has relationships with several pharmaceutical companies, including Amgen Inc., Procter & Gamble, Sanofi-Aventis, and Novartis Pharmaceuticals Corp., which manufactures the bisphosphonate Reclast (zoledronic acid).
