A multi-centered, randomized, double-blind placebo controlled study of risedronate on bone mineral density and bone turnover markers in osteoporotic Chinese women

Abstract

Risedronate has been shown to be effective in preventing fractures in Caucasian women. To assess the efficacy and tolerability of Risedronate 5 mg/d versus placebo in Chinese postmenopausal women, we studied 65 osteoporotic women with BMD T score £2.5 at the spine. BMD at L1-4 lumbar spine, femoral neck and total hip region, serum osteocalin and urine N-telopeptide were assessed at 3 monthly intervals. No difference in BMD and bone turnover markers was observed at baseline between the 2 groups. Risedronate significantly increased BMD at 3 months [lumbar spine 3.5% (p<0.0001), femoral neck 1.9% (p<0.02), total hip 2.7% (p<0.0001)], and 12 months [lumbar spine 6.2% (p<0.0001), femoral neck 1.9% (p<0.02), total hip 2.7% (p<0.0001)], whereas no difference in BMD was seen in the placebo group. Risedronate significantly decreased osteocalcin by means of 2.9% and 11.4% and N-telopeptide by means of 31.7% and 40.1% at 3 and 6 month respectively from placebo. Signifi- cant differences were already observed at the lumbar spine BMD and urinary N-telopeptide at month 3 between the 2 treatment groups. The change in NTx at 3 months correlated to the change in BMD at 12 months. In conclusion, as similar to Caucasian women, early efficacy of Risedronate on BMD and bone turnover markers is seen in postmenopausal osteoporotic Asian women.