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A phase III randomized, double-blind, placebo-controlled trial of the denosumab biosimilar QL1206 in postmenopausal Chinese women with osteoporosis and high fracture risk
Acta Pharmacologica Sinica ( IF 8.2 ) Pub Date : 2022-07-27 , DOI: 10.1038/s41401-022-00954-y
Hao Zhang 1 , Jie-Mei Gu 1 , Ai-Jun Chao 2 , Qun Cheng 3 , Dong-Hui Teng 4 , Jin-Ming Yu 5 , Bing-Wu Wang 6 , Ya-Nan Huo 7 , Li Mao 8 , Qiu Zhang 9 , Hong Yang 10 , Shi-Gui Yan 11 , Ke-Qin Zhang 12 , Xue-Ling Zhao 13 , Hua Lin 14 , Yu Pei 15 , Zhong Yuan 16 , Ru-Chun Dai 17 , Liang He 18 , Li Chen 19 , Yong-Feng Su 20 , Zhong-Liang Deng 21 , Li You 22 , Bo Ban 23 , Mei Zhu 24 , You-Liang Cao 25 , Yi-Kun Zhu 26 , Zhi-Jun Li 27 , Zhi Zhang 28 , Cheng-Qing Yi 29 , Yi-Bing Lu 30 , Guang Wang 31 , Cui-Cui Han 32 , Zhen-Jiang Wang 33 , Xian-Xing Li 34 , Zhen-Lin Zhang 1
Affiliation  

The current study evaluated the efficacy and safety of a denosumab biosimilar, QL1206 (60 mg), compared to placebo in postmenopausal Chinese women with osteoporosis and high fracture risk. At 31 study centers in China, a total of 455 postmenopausal women with osteoporosis and high fracture risk were randomly assigned to receive QL1206 (60 mg subcutaneously every 6 months) or placebo. From baseline to the 12-month follow-up, the participants who received QL1206 showed significantly increased bone mineral density (BMD) values (mean difference and 95% CI) in the lumbar spine: 4.780% (3.880%, 5.681%), total hip :3.930% (3.136%, 4.725%), femoral neck 2.733% (1.877%, 3.589%) and trochanter: 4.058% (2.791%, 5.325%) compared with the participants who received the placebo. In addition, QL1206 injection significantly decreased the serum levels of C-terminal crosslinked telopeptides of type 1 collagen (CTX): −77.352% (−87.080%, −66.844%), and N-terminal procollagen of type l collagen (P1NP): −50.867% (−57.184%, −45.217%) compared with the placebo over the period from baseline to 12 months. No new or unexpected adverse events were observed. We concluded that compared with placebo, QL1206 effectively increased the BMD of the lumbar spine, total hip, femoral neck and trochanter in postmenopausal Chinese women with osteoporosis and rapidly decreased bone turnover markers. This study demonstrated that QL1206 has beneficial effects on postmenopausal Chinese women with osteoporosis and high fracture risk.

更新日期:2022-07-27
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