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Year : 2015  |  Volume : 19  |  Issue : 1  |  Page : 148-154

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

1 Pitale Diabetes and Hormone Centre, Nagpur, Maharashtra, India
2 Health and Research Centre, Trivandrum, Kerala, India
3 Rathi Hospital and Research Centre, Ahmedabad, Gujarat, India
4 Deshmukh Clinic and Research Centre, Pune, Maharashtra, India
5 Bangalore Diabetes Hospital, Bangalore, India
6 Medisys Clinisearch India, Bangalore, India
7 M. S. Ramaiah Clinical Research Center, Bangalore, Karnataka, India
8 Department of Medicine, Sir Ganga Ram Hospital, New Delhi, India
9 Sushrut Hospital Research Centre, Nagpur, Maharashtra, India
10 Centre for Knee and Hip Surgery, Vadodara, Gujarat, India
11 Father Muller Medical College, Mangalore, Karnataka, India
12 GlaxoSmithKline, Mumbai, Maharashtra, India
13 GlaxoSmithKline, King of Prussia, Pennsylvania, USA

Correspondence Address:
Barbara G Kravitz
MS, Publications Manager, Publications and Disclosure Practices, Global Medical Platforms and Capabilities, RD Chief Medical Office, 2301 Renaissance Blvd RNo41o, King of Prussia, PA 19406
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Source of Support: Shailesh Pitale, Mathew Thomas, Gaurav Rathi, Vaishali Deshmukh, Prasanna Kumar, Sanjay Reddy, Naresh Shetty, Atul Kakar, Sushrut Babhulkar, Bharat Mody, and Jacob Chacko declare no conflict of interest. Sudeep Acharya, Sadhna Joglekar, Barbara Kravitz, Brian Waterhouse, Antonio Nino, and Lorraine A. Fitzpatrick are employees of GlaxoSmithKline and receive stock/ stock options in the company. Vipul Halbe is an employee of GlaxoSmithKline but does not receive stock/stock options in the company., Conflict of Interest: This study was sponsored by GlaxoSmithKline,

DOI: 10.4103/2230-8210.146871

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Introduction: Osteoporosis is a serious condition affecting up to 50% of Indian postmenopausal women. Denosumab reduces bone resorption by targeting the receptor activator of nuclear factor-κB ligand. This study assessed the efficacy and safety of denosumab in Indian postmenopausal women with osteoporosis. Materials and Methods: In this double-blind, multicenter, phase 3 study, 250 Indian postmenopausal women 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 D 3 ≥ 400 IU daily. The primary end point was mean percent change in bone mineral density (BMD) at the lumbar spine from baseline to Month 6. Secondary end points included mean percent change from baseline in BMD at total hip, femoral neck, 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 fractures 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 BMD and decreasing bone turnover markers over a six-month period in Indian postmenopausal women.

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