{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,25]],"date-time":"2025-07-25T10:33:34Z","timestamp":1753439614534},"reference-count":34,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2022,1,12]],"date-time":"2022-01-12T00:00:00Z","timestamp":1641945600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,1,12]],"date-time":"2022-01-12T00:00:00Z","timestamp":1641945600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd, China."}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Arch Osteoporos"],"published-print":{"date-parts":[[2022,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>\n                           <jats:italic>Summary<\/jats:italic>\n                        <\/jats:title>\n                <jats:p>Zoledronic acid (ZOL) is a therapy inhibiting bone resorption. In this study, generic ZOL (Yigu\u00ae) showed its clinical efficacy consistency with original ZOL (Aclasta\u00ae) in Chinese postmenopausal women with osteoporosis. This study provides a practical basis for the application of Yigu\u00ae in Chinese population.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Introduction<\/jats:title>\n                <jats:p>Yigu\u00ae has been approved its bioequivalence to Aclasta\u00ae. However, the clinical efficacy and safety of Yigu\u00ae have not been evaluated yet. Here, we compared the effectiveness and safety between Yigu\u00ae and Aclasta\u00ae in Chinese postmenopausal women with osteoporosis and assessed the efficacy of intravenous infusion of ZOL.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>This was a randomized open-label, active-controlled study in postmenopausal women with osteoporosis of 14 clinical centers in China. Postmenopausal women with osteoporosis were recruited and randomized to receive a single infusion of 5\u00a0mg Yigu\u00ae or Aclasta\u00ae. The primary endpoint was the percentage change in bone mineral density (BMD) at lumbar spine after 12\u00a0months of treatment and was assessed for equivalence. The secondary endpoint was the percentage change in BMD at proximal femur after 12\u00a0months. Additional secondary endpoints were percentage changes in BMD at the above sites after 6\u00a0months of treatment and changes in bone turnover biomarkers during ZOL treatment. Safety was also evaluated and compared between two groups.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>A total of 458 postmenopausal women with osteoporosis were enrolled (<jats:italic>n<\/jats:italic>\u2009=\u2009227, Yigu\u00ae; <jats:italic>n<\/jats:italic>\u2009=\u2009231, Aclasta\u00ae). The mean percentage change in the BMD had no statistical difference at the lumbar spine (5.32% vs 5.18%), total hip (2.72% vs 2.83%), and femoral neck (2.37% vs 2.81%) between Yigu\u00ae and Aclasta\u00ae groups after 12\u00a0months of treatment. The mean difference of BMD change at the lumbar spine after 12\u00a0months between two groups was 0.15% (95% CI:\u2009\u2212\u20090.71 to 1.00, equivalence margin:\u2009\u2212\u20091.5%, 1.5%), demonstrating the treatments were equivalent. Meanwhile, the decreases in the P1NP and \u03b2-CTX showed no difference between two groups after 14\u00a0days and 6 and 12\u00a0months of treatment. As regards the whole sample, BMD significantly increased after 12\u00a0months of treatment. Also, serum C-terminal telopeptide of type 1 collagen (\u03b2-CTX) and procollagen 1\u00a0N-terminal peptide (P1NP) significantly decreased at each visit period. The overall adverse events were comparable and quite well between two groups.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>Intravenous infusion of zoledronic acid achieved the potent anti-resorptive effects which led to significant increase in BMD of Chinese postmenopausal women with osteoporosis. Yigu\u00ae was equivalent to Aclasta\u00ae with respect to efficacy and safety.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s11657-021-01052-y","type":"journal-article","created":{"date-parts":[[2022,1,12]],"date-time":"2022-01-12T16:02:38Z","timestamp":1642003358000},"update-policy":"http:\/\/dx.doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Efficacy of Yigu\u00ae versus Aclasta\u00ae in Chinese postmenopausal women with osteoporosis: a multicenter prospective study"],"prefix":"10.1007","volume":"17","author":[{"given":"Mei","family":"Li","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Qun","family":"Cheng","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ya-nan","family":"Huo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ai-jun","family":"Chao","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Liang","family":"He","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Qing-yun","family":"Xue","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jin","family":"Xu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shi-gui","family":"Yan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hui","family":"Jin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zhen-lin","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jian-hua","family":"Lin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiao-lan","family":"Jin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"You-jia","family":"Xu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Feng","family":"Liu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wei-bo","family":"Xia","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2022,1,12]]},"reference":[{"key":"1052_CR1","doi-asserted-by":"publisher","unstructured":"(1993) Consensus development conference: diagnosis, prophylaxis, and treatment of osteoporosis. 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