A randomized placebo-controlled trial of the efficacy of denosumab in Indian postmenopausal XXXX with @entity170 .

@entity1 @entity79 @entity170 @entity174
INTRODUCTION: @entity170 is a serious condition affecting up to 50% of Indian postmenopausal @entity1 . Denosumab reduces bone resorption by targeting the receptor activator of nuclear factor-kB ligand. This study assessed the efficacy and safety of denosumab in Indian postmenopausal @entity1 with @entity170 . MATERIALS AND METHODS: In this double-blind, multicenter, phase 3 study, 250 Indian postmenopausal @entity1 aged 55 to 75 years (T-score <-2.5 and >-4.0 at the lumbar spine or total hip; serum 25(OH) D levels >= 20 ng/mL) were randomized to receive one subcutaneous dose of denosumab 60 mg or placebo. All subjects received oral calcium >= 1000 mg and vitamin D3 >=  400 IU daily. The primary end point was mean percent change in @entity79 ( @entity79 ) at the lumbar spine from baseline to Month 6. Secondary end points included mean percent change from baseline in @entity79 , and trochanter at Month 6 and median percent change from baseline in bone turnover markers at Months 1, 3, and 6. RESULTS: Total 225 subjects (denosumab = 111, placebo = 114) completed the six-month study. Baseline demographics were similar between groups. A 3.1% (95% confidence interval, 1.9%, 4.2%) increase favoring denosumab versus placebo was seen for the primary end point (P < 0.0001). Denosumab demonstrated a significant treatment benefit over placebo for the secondary end points. There were no @entity174 or withdrawals due to adverse events. CONCLUSIONS: Consistent with results from studies conducted in other parts of the world, denosumab was well tolerated and effective in increasing @entity79 and decreasing bone turnover markers over a six-month period in Indian postmenopausal @entity1 .
