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Colin R. Dormuth, ScD; Greg Carney, BSc; Bruce Carleton, BPharm, PharmD; Ken Bassett, MD, PhD; James M. Wright, MD, PhD

Arch Intern Med. 2009;169(15):1395-1402.

Background  Clinical trials and meta-analyses have found that rosiglitazone maleate, a thiazolidinedione that is prescribed for type 2 diabetes mellitus, increases the risk of fractures in women. The association between the use of thiazolidinediones and fractures in men and women is not adequately understood.

Methods  We conducted a prospective cohort study. The primary outcome was peripheral fractures in men and women who were exposed to thiazolidinediones compared with sulfonylureas. We studied 84 339 patients from British Columbia, Canada, who began treatment with a thiazolidinedione or a sulfonylurea. The association between the use of thiazolidinediones and fractures was examined using multivariate-adjusted Cox models.

Results  The mean age of the patients in the study was 59 years, and 43% were women. In this cohort, treatment with a thiazolidinedione was associated with a 28% increased risk of peripheral fractures compared with treatment with a sulfonylurea (hazard ratio [HR], 1.28; 95% confidence interval [CI], 1.10-1.48). The use of pioglitazone hydrochloride was associated with an increased risk of peripheral fracture of 77% in women (HR, 1.76; 95% CI 1.32-2.38). Compared with exposure to sulfonylureas, exposure to pioglitazone was associated with more peripheral fractures in men (HR, 1.61; 95% CI 1.18-2.20), but we did not observe a similar association with exposure to rosiglitazone (HR, 1.00; 95% CI, 0.75-1.34).

Conclusions  Both men and women who take thiazolidinediones could be at increased risk of fractures. Pioglitazone may be more strongly associated with fractures than rosiglitazone. Larger observational studies are needed, and fracture data from clinical trials need to be fully published so that fracture risks can be known with greater certainty.

Author Affiliations: Departments of Anesthesiology, Pharmacology, and Therapeutics (Drs Dormuth, Bassett, and Wright), Family Practice (Dr Bassett), and Medicine (Dr Wright), Therapeutics Initiative (Drs Dormuth, Bassett, and Wright and Mr Carney), and Pharmaceutical Outcomes and Policy Innovations Programme, Faculties of Medicine (Pediatrics) and Pharmaceutical Sciences (Dr Carleton), University of British Columbia, and Pharmaceutical Outcomes Programme, Child & Family Research Institute (Dr Carleton), Vancouver, Canada.

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