Effects of denosumab in postmenopausal women with osteoporosis from India.

Purpose: To determine effects of denosumab (DMAb) in postmenopausal osteoporotic women from India. Materials and Methods: Double-blind, multicenter study. Two hundred and fifty Indian postmenopausal women from 55 to 75 years of age, with osteoporosis (dual-energy X-ray absorptiometry bone mineral density (DXA BMD)) equivalent to a T score of <-0.5 and >- 4.0 at either lumbar spine (LS) or total hip (TH) and serum levels of 25-(OH) vitamin D³20 ng/mLwere randomized to DMAb 60 mg subcutaneous (SC) injection or placebo. BMD, serum bone turnover markers (serum C-terminal telopeptide of type I collagen (s-CTx) and serum procollagen type I N propeptide (s-PINP)), and safety were evaluated. All subjects received daily calcium (≥1,000 mg) and vitamin D (³400 IU). All sites obtained Ethics Committee approval and all subjects signed informed consent. Results: Baseline age and years since menopause were similar with mean 62.6 years (standard deviation (SD) 4.96) and median 15 years since menopause. At month 6, compared with placebo, the DMAb group showed a statistically significant increase in percentage change in BMD from baseline at the LS (primary endpoint) (3.1%; 95% CI: 1.9%, 4.2%; P < 0.0001), TH (1.7%; 95% confidence interval (CI): 0.9%, 2.5%; P< 0.0001), femoral neck (FN) (2.3%; 95% CI: 1.1%, 3.4%; P = 0.0001), and trochanter (1.8%; 95% CI: 0.8%, 2.8%; P = 0.0006]. A decrease in percentage change from baseline was observed for s-CTx (median: -33.4%; 95% CI: -40.8%; -26.0%; P< 0.0001 ] and s-PINP (median: -37.6%; 95% CI: -44.2%, -31.2%; P < 0.0001). 31 % DMAb and 37% placebo subjects experienced adverse events (AEs). The most common DMAb AE was upper respiratory infection (6%) vs 2% in the placebo group. One subject (DMAb) and three (placebo) experienced seriousAEs (SAEs), none attributed to study drug. Conclusions: After 6 months, DMAb statistically significantly increased percentage change from baseline in BMDatthe LS,TH, FN, and trochanter; and significantly decreased percentage change from baseline s-CTx and s-PINP compared to placebo. No new or unexpected safety signals were detected. This study was sponsored by GlaxoSmithKline Pharmaceuticals. [ABSTRACT FROM AUTHOR]