A randomized placebo-controlled trial of the efficacy of denosumab in Indian postmenopausal women with osteoporosis
| Autor: | Mathew Thomas, Prasanna Kumar, Sanjay Reddy, Sushrut Babhulkar, Vipul Halbe, Sudeep Acharya, B. S. Mody, Naresh Shetty, Antonio Nino, Vaishali Deshmukh, Sadhna J Joglekar, Lorraine A. Fitzpatrick, Jacob Chacko, Barbara G. Kravitz, Gaurav Rathi, Shailesh Pitale, Brian Waterhouse, Atul Kakar |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2015 |
| Předmět: |
medicine.medical_specialty
Endocrinology Diabetes and Metabolism Osteoporosis Placebo-controlled study India Placebo lcsh:Diseases of the endocrine glands. Clinical endocrinology Bone resorption Bone remodeling Endocrinology Internal medicine medicine Bone mineral density lcsh:RC799-869 Femoral neck Bone mineral lcsh:RC648-665 postmenopausal business.industry denosumab medicine.disease osteoporosis Surgery medicine.anatomical_structure Denosumab lcsh:Diseases of the digestive system. Gastroenterology Original Article business bone turnover markers medicine.drug |
| Zdroj: | Indian Journal of Endocrinology and Metabolism Indian Journal of Endocrinology and Metabolism, Vol 19, Iss 1, Pp 148-154 (2015) |
| ISSN: | 2230-9500 2230-8210 |
| Popis: | 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 -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. |
| Databáze: | OpenAIRE |
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