Aim: The objectives of the study were to determine whether thiazolidinedione (TZD) use is associated with an increased risk of fracture in men and women with type 2 diabetes mellitus and to compare the effects of pioglitazone and rosiglitazone.
Materials and methods: A research database of integrated pharmacy and medical claims was analysed using Cox models adjusted for age, gender, chronic obstructive pulmonary disease, asthma, osteoporosis, stroke, prior fracture and chronic disease score. Patients were followed for 540 days.
Results: There was a 39% higher [adjusted hazard ratio (HR), 1.39; 95% confidence interval (CI), 1.32-1.46] incidence of fractures in men and women exposed to a TZD (n = 69047; age = 56 +/- 5 years; 59% men; 48% rosiglitazone) compared with that in control patients (n = 75352; age = 56 +/- 5 years; 51% men). Men treated with a TZD had a higher likelihood of fracture than control patients (adjusted HR rosiglitazone, 1.47; 95% CI, 1.38-1.56; adjusted HR pioglitazone, 1.43; 95% CI, 1.34-1.52). The HRs associated with pioglitazone (adjusted HR, 1.43; 95% CI, 1.34-1.52) and rosiglitazone (adjusted HR, 1.47; 95% CI, 1.38-1.56) were almost identical. TZD use was associated with a higher fracture risk in women aged above and below 50 years and in men aged above 50 years.
Conclusions: Our findings add support to the growing literature that TZD treatment is associated with an increased risk of fractures in both men and women, that effects of rosiglitazone and pioglitazone are similar and that fracture risk is increased even in younger women.