Effect of raloxifene on clinical fractures in Asian women with postmenopausal osteoporosis.

Osteoporosis is becoming a major public health problem in Asian countries, with a rapid increase in osteoporotic fractures projected as urbanization increases, particularly in China. The purpose of this post hoc analysis was to assess the effects of 12 months of treatment with raloxifene on the incidence of clinical fractures in postmenopausal Asian women, compared to a placebo, by combining two independently designed studies (one Japanese study and one Chinese study). A total of 488 women, 284 in Japan and 204 in China were included in the analysis. Baseline characteristics (mean +/- SD) for the Japanese and Chinese women were: age, 64.8 +/- 6.3 years and 65.3 +/- 6.0 years; body mass index, 21.8 +/- 2.8 kg/m(2) and 23.0 +/- 2.9 kg/m(2); and prevalent vertebral fractures, 26.4% and 13.7%, respectively. In both studies, the clinical vertebral and nonvertebral fractures were confirmed by radiographs or clinical reports at a central research facility. From the two combined studies, the incidence of new clinical vertebral fractures was significantly lower in the raloxifene 60 mg/day (RLX60) group (0 out of 194, P = 0.01) and in the pooled raloxifene group (those taking 60 mg/day and those taking 120 mg/day) (0 out of 289, P = 0.002), compared with the placebo group (7 out of 199, 3.5%). The pooled raloxifene group, as well as the RLX60 group, also had a significantly lower incidence of any new clinical fracture (P = 0.001 and P = 0.01, respectively) compared to the placebo group. In conclusion, raloxifene treatment at 60 mg/day for 1 year resulted in a significant reduction in the risk of new clinical vertebral fractures and any new clinical fracture in postmenopausal Asian women with osteoporosis.