{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T22:32:26Z","timestamp":1792794746970,"version":"4.5.0"},"reference-count":9,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"1","content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2021,1]]},"abstract":"\n OBJECTIVE:<\/jats:title>\n The study assessed the efficacy, safety, pharmacokinetic (PK), and immunogenicity profiles of denosumab-biosimilar and denosumab-reference in postmenopausal osteoporotic women from India.<\/jats:p>\n <\/jats:sec>\n \n MATERIALS AND METHODS:<\/jats:title>\n \n In this randomized, assessor-blind, active-control, multicenter trial, 114 patients were randomly allocated to receive denosumab-biosimilar (\n n<\/jats:italic>\n = 58) or denosumab-reference (\n n<\/jats:italic>\n = 56) at a subcutaneous dose of 60 mg every 6 months, for a year. Vitamin D and oral calcium were given daily. Lumbar spine bone mineral density (BMD) change was the primary end point.\n <\/jats:p>\n <\/jats:sec>\n \n RESULTS:<\/jats:title>\n \n Of 114 randomized patients, 111 (denosumab-biosimilar,\n n<\/jats:italic>\n = 56; denosumab-reference,\n n<\/jats:italic>\n = 55) completed the study. All 114 patients were part of safety and immunogenicity analyses, 110 (denosumab-biosimilar,\n n<\/jats:italic>\n = 56; denosumab-reference,\n n<\/jats:italic>\n = 54) were part of efficacy analysis, and 20 (denosumab-biosimilar,\n n<\/jats:italic>\n = 10; denosumab-reference,\n n<\/jats:italic>\n = 10) were part of PK analysis. The bone mineral density (BMD) (lumbar spine) percent change at 1 year with denosumab-biosimilar and denosumab-reference (7.22 vs. 7.62; difference:\u22120.40; 95% confidence interval: \u22125.92, 5.12) showed no statistically relevant difference. Likewise, alkaline phosphatase (bone-specific) and PK parameters also did not show statistically relevant differences. Adverse events were reported in 44.83% of patients on denosumab-biosimilar versus 33.93% of patients on denosumab-reference; most events were mild or moderate and not related to the study drugs. No patients showed anti-denosumab antibody positivity.\n <\/jats:p>\n <\/jats:sec>\n \n CONCLUSIONS:<\/jats:title>\n Denosumab-biosimilar and denosumab-reference showed biosimilarity in osteoporotic postmenopausal women. Availability of denosumab-biosimilar provides a treatment alternative for patients.<\/jats:p>\n <\/jats:sec>","DOI":"10.4103\/ijp.ijp_346_19","type":"journal-article","created":{"date-parts":[[2021,4,28]],"date-time":"2021-04-28T09:02:45Z","timestamp":1619600565000},"page":"6-12","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":11,"title":["Denosumab biosimilar in postmenopausal osteoporotic women"],"prefix":"10.4103","volume":"53","author":[{"given":"Inderjeet","family":"Singh","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vinu","family":"Jose","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ronak","family":"Patel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sumit","family":"Arora","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"R3-3-20240903","doi-asserted-by":"crossref","first-page":"841","DOI":"10.2147\/IJWH.S54623","article-title":"Epidemiology and treatment of osteoporosis in women: An Indian perspective","volume":"7","author":"Khadilkar","year":"2015","journal-title":"Int J Womens Health"},{"key":"R4-3-20240903","first-page":"1","article-title":"American Association of Clinical Endocrinologists and American College of Endocrinology Clinical Practice Guidelines for the Diagnosis and Treatment of Postmenopausal Osteoporosis \u2013 2016","volume":"22","author":"Camacho","year":"2016","journal-title":"Endocr Pract Off J Am Coll Endocrinol Am Assoc Clin Endocrinol"},{"key":"R6-3-20240903","doi-asserted-by":"crossref","first-page":"756","DOI":"10.1056\/NEJMoa0809493","article-title":"Denosumab for prevention of fractures in postmenopausal women with osteoporosis","volume":"361","author":"Cummings","year":"2009","journal-title":"N Engl J Med"},{"key":"R7-3-20240903","doi-asserted-by":"crossref","first-page":"148","DOI":"10.4103\/2230-8210.146871","article-title":"A randomized placebo-controlled trial of the efficacy of denosumab in Indian postmenopausal women with osteoporosis","volume":"19","author":"Pitale","year":"2015","journal-title":"Indian J Endocrinol Metab"},{"key":"R8-3-20240903","doi-asserted-by":"crossref","first-page":"3163","DOI":"10.1210\/jc.2016-1801","article-title":"Denosumab or zoledronic acid in postmenopausal women with osteoporosis previously treated with oral bisphosphonates","volume":"101","author":"Miller","year":"2016","journal-title":"J Clin Endocrinol Metab"},{"key":"R9-3-20240903","doi-asserted-by":"crossref","first-page":"153","DOI":"10.1359\/jbmr.0809010","article-title":"Comparison of the effect of denosumab and alendronate on BMD and biochemical markers of bone turnover in postmenopausal women with low bone mass: A randomized, blinded, phase 3 trial","volume":"24","author":"Brown","year":"2009","journal-title":"J Bone Miner Res"},{"key":"R12-3-20240903","doi-asserted-by":"crossref","first-page":"1131","DOI":"10.1007\/s00198-011-1786-8","article-title":"Dose-response study of denosumab on bone mineral density and bone turnover markers in Japanese postmenopausal women with osteoporosis","volume":"23","author":"Nakamura","year":"2012","journal-title":"Osteoporos Int"},{"key":"R13-3-20240903","doi-asserted-by":"crossref","first-page":"530","DOI":"10.1002\/jbmr.251","article-title":"Effects of denosumab on bone turnover markers in postmenopausal osteoporosis","volume":"26","author":"Eastell","year":"2011","journal-title":"J Bone Miner Res Off J Am Soc Bone Miner Res"},{"key":"R14-3-20240903","doi-asserted-by":"crossref","first-page":"441","DOI":"10.4103\/2230-8210.137482","article-title":"Osteoporosis treatment in India: Call for action","volume":"18","author":"Varthakavi","year":"2014","journal-title":"Indian J Endocrinol Metab"}],"container-title":["Indian Journal of Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ovid.com\/10.4103\/ijp.IJP_346_19","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,27]],"date-time":"2026-08-27T15:26:43Z","timestamp":1787844403000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ovid.com\/10.4103\/ijp.IJP_346_19"}},"subtitle":["A randomized, assessor-blind, active-controlled clinical trial"],"short-title":[],"issued":{"date-parts":[[2021,1]]},"references-count":9,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2021]]}},"URL":"https:\/\/doi.org\/10.4103\/ijp.ijp_346_19","relation":{},"ISSN":["0253-7613"],"issn-type":[{"value":"0253-7613","type":"print"}],"subject":[],"published":{"date-parts":[[2021,1]]}}}