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Bisphosphonate Use and Atypical Fractures of the Femoral Shaft



- New England Journal of Medicine

05/05/2011 - Background: Studies show conflicting results regarding the possible excess risk of atypical fractures of the femoral shaft associated with bisphosphonate use.

Methods:
In Sweden, 12,777 women 55 years of age or older sustained a fracture of the femur in 2008. We reviewed radiographs of 1234 of the 1271 women who had a subtrochanteric or shaft fracture and identified 59 patients with atypical fractures. Data on medications and coexisting conditions were obtained from national registries. The relative and absolute risk of atypical fractures associated with bisphosphonate use was estimated by means of a nationwide cohort analysis. The 59 case patients were also compared with 263 control patients who had ordinary subtrochanteric or shaft fractures.

Results:
The age-adjusted relative risk of atypical fracture was 47.3 (95% confidence interval [CI], 25.6 to 87.3) in the cohort analysis. The increase in absolute risk was 5 cases per 10,000 patient-years (95% CI, 4 to 7). A total of 78% of the case patients and 10% of the controls had received bisphosphonates, corresponding to a multivariable-adjusted odds ratio of 33.3 (95% CI, 14.3 to 77.8). The risk was independent of coexisting conditions and of concurrent use of other drugs with known effects on bone. The duration of use influenced the risk (odds ratio per 100 daily doses, 1.3; 95% CI, 1.1 to 1.6). After drug withdrawal, the risk diminished by 70% per year since the last use (odds ratio, 0.28; 95% CI, 0.21 to 0.38).

Conclusion:
These population-based nationwide analyses may be reassuring for patients who receive bisphosphonates. Although there was a high prevalence of current bisphosphonate use among patients with atypical fractures, the absolute risk was small. (Funded by the Swedish Research Council.)

Dr. Aspenberg reports receiving consulting fees from Eli Lilly and Amgen and grant support to his institution, Linköping University, from Eli Lilly and Amgen, as well as holding stock in AddBIO, a company trying to commercialize a method for bisphosphonate coating of implants to be inserted in bone, and holding a patent for this method. No other potential conflict of interest relevant to this article was reported.

Source Information:
From the Department of Experimental and Clinical Medicine, Faculty of Health Science, Linköping University, Linköping (J.S., P.A.); and the Department of Surgical Sciences, Section of Orthopedics, and Uppsala Clinical Research Center, Uppsala University, Uppsala (K.M.) — both in Sweden.

Address reprint requests to Dr. Aspenberg at the Department of Experimental and Clinical Medicine, Faculty of Health Sciences, Linköping University, SE-581 85 Linköping, Sweden, or at per.aspenberg@liu.se.

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