A randomized placebo-controlled trial of the efficacy of denosumab in Indian postmenopausal women with osteoporosis

• DOI: 10.4103/2230-8210.146871
• Publication Date: 2014-12-12T07:11:20Z
• Authors: BarbaraG Kravitz; Shailesh Pitale; Mathew Thomas; Gaurav Rathi; Vaishali Deshmukh; Prasanna Kumar; Sanjay Reddy; Naresh Shetty; Atul Kakar; Sushrut Babhulkar; Bharat Mody; Jacob Chacko; Sudeep Acharya; Sadhna Joglekar; Vipul Halbe; Brian Waterhouse; AntonioJ Nino; LorraineA Fitzpat...
• Keywords: Denosumab; Clinical endpoint; Bone remodeling

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