"A phase III randomized, double-blind, placebo-controlled trial of the denosumab biosimilar QL1206 in postmenopausal Chinese women with osteoporosis and high fracture risk"

作者全名："Zhang, Hao; Gu, Jie-Mei; Chao, Ai-Jun; Cheng, Qun; Teng, Dong-Hui; Yu, Jin-Ming; Wang, Bing-Wu; Huo, Ya-Nan; Mao, Li; Zhang, Qiu; Yang, Hong; Yan, Shi-Gui; Zhang, Ke-Qin; Zhao, Xue-Ling; Lin, Hua; Pei, Yu; Yuan, Zhong; Dai, Ru-Chun; He, Liang; Chen, Li; Su, Yong-Feng; Deng, Zhong-Liang; You, Li; Ban, Bo; Zhu, Mei; Cao, You-Liang; Zhu, Yi-Kun; Li, Zhi-Jun; Zhang, Zhi; Yi, Cheng-Qing; Lu, Yi-Bing; Wang, Guang; Han, Cui-Cui; Wang, Zhen-Jiang; Li, Xian-Xing; Zhang, Zhen-Lin"

作者地址："[Zhang, Hao; Gu, Jie-Mei; Zhang, Zhen-Lin] Shanghai Jiao Tong Univ Affiliated Peoples Hosp 6, Shanghai Clin Res Ctr Bone Dis, Dept Osteoporosis & Bone Dis, Shanghai 200233, Peoples R China; [Chao, Ai-Jun] Tianjin Hosp, Dept Osteointernal, Tianjin 300211, Peoples R China; [Cheng, Qun] Fudan Univ, Dept Osteoporosis, Huadong Hosp, Shanghai 200040, Peoples R China; [Teng, Dong-Hui] Tianjin First Cent Hosp, Dept Orthoped, Tianjin 300192, Peoples R China; [Yu, Jin-Ming] Peoples Hosp Guangxi Zhuang Autonomous Reg, Dept Endocrinol, Nanning 530016, Peoples R China; [Wang, Bing-Wu] Weifang Peoples Hosp, Dept Spine Surg, Weifang 261000, Peoples R China; [Huo, Ya-Nan] Nanchang Univ, Dept Endocrinol, Jiangxi Prov Peoples Hosp, Nanchang 330006, Jiangxi, Peoples R China; [Mao, Li] Nanjing Med Univ, Dept Endocrinol, Affiliated Huaian 1 Peoples Hosp, Huaian 223300, Peoples R China; [Zhang, Qiu] Anhui Med Univ, Dept Endocrinol, Affillated Hosp 1, Hefei 230022, Peoples R China; [Yang, Hong] Ruian Peoples Hosp, Dept Endocrinol, Wenzhou 325200, Peoples R China; [Yan, Shi-Gui] Zhejiang Univ, Affiliated Hosp 2, Dept Orthoped, Sch Med, Hangzhou 310009, Peoples R China; [Zhang, Ke-Qin] Tongji Univ, Dept Endocrinol, Tongji Hosp, Shanghai 200065, Peoples R China; [Zhao, Xue-Ling] Kunming Med Univ, Dept Orthoped, Affillated Hosp 1, Kunming 650032, Yunnan, Peoples R China; [Lin, Hua] Nanjing Drum Tower Hosp, Metab Bone Dis Prevent & Treatment Res Ctr, Nanjing 210008, Peoples R China; [Pei, Yu] Chinese Peoples Liberat Army Gen Hosp, Dept Endocrinol, Beijing 100853, Peoples R China; [Yuan, Zhong] Nanchang Hongdu Hosp TCM, Dept Osteoporosis, Nanchang 330006, Jiangxi, Peoples R China; [Dai, Ru-Chun] Cent South Univ, Dept Endocrinol, Xiangya Hosp 2, Changsha 410011, Peoples R China; [He, Liang] Beijing Jishuitan Hosp, Dept Orthoped, Beijing 100035, Peoples R China; [Chen, Li] Shandong Univ, Dept Endocrinol, Qilu Hosp, Jinan 250012, Peoples R China; [Su, Yong-Feng] Inner Mongolia Baogang Hosp, Dept Endocrinol, Baotou 014010, Peoples R China; [Deng, Zhong-Liang] Chongqing Med Univ, Dept Spine Surg, Affiliated Hosp 2, Chongqing 400010, Peoples R China; [You, Li] Shanghai Jiao Tong Univ, Shanghai Gen Hosp, Dept Endocrinol, Shanghai 200080, Peoples R China; [Ban, Bo] Jining Med Univ, Dept Endocrinol, Affiliated Hosp, Jining 272007, Peoples R China; [Zhu, Mei] Tianjin Med Univ Gen Hosp, Dept Endocrinol, Tianjin 300052, Peoples R China; [Cao, You-Liang] Third Peoples Hosp Yunnan Prov, Dept Orthoped, Kunming 650011, Yunnan, Peoples R China; [Zhu, Yi-Kun] Shanxi Med Univ, Dept Endocrinol, Hosp 2, Taiyuan 030001, Peoples R China; [Li, Zhi-Jun] Bengbu Med Coll, Dept Rheumatol & Immunol, Affillated Hosp 1, Bengbu 233004, Peoples R China; [Zhang, Zhi] Suining Cent Hosp, Dept Spine Surg, Suining 629000, Peoples R China; [Yi, Cheng-Qing] Shanghai Pudong Hosp, Dept Orthoped, Shanghai 201399, Peoples R China; [Lu, Yi-Bing] Nanjing Med Univ, Dept Endocrinol, Affiliated Hosp 2, Nanjing 210011, Peoples R China; [Wang, Guang] Capital Med Univ, Beijing Chao Yang Hosp, Dept Endocrinol, Beijing 100020, Peoples R China; [Han, Cui-Cui] Qilu Pharmaceut Co Ltd, Dept Med, Jinan 250100, Peoples R China; [Wang, Zhen-Jiang] Qilu Pharmaceut Co Ltd, Dept Project, Jinan 250100, Peoples R China; [Li, Xian-Xing] Qilu Pharmaceut Co Ltd, Dept Stat Anal, Jinan 250100, Peoples R China"

通信作者："Zhang, ZL (通讯作者)，Shanghai Jiao Tong Univ Affiliated Peoples Hosp 6, Shanghai Clin Res Ctr Bone Dis, Dept Osteoporosis & Bone Dis, Shanghai 200233, Peoples R China."

来源：ACTA PHARMACOLOGICA SINICA

ESI学科分类：PHARMACOLOGY & TOXICOLOGY

WOS号：WOS:000830960900002

JCR分区：Q1

影响因子：8.2

年份：2022

卷号：　

期号：　

开始页：　

结束页：　

文献类型：Article; Early Access

关键词：denosumab biosimilar; postmenopausal osteoporosis; Chinese women; bone mineral density; bone turnover markers; adverse events

摘要："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."

基金机构："Qilu Pharmaceutical Co. Ltd, Jinan, China"

基金资助正文："We thank the study participants for their invaluable cooperation. The study was sponsored by Qilu Pharmaceutical Co. Ltd, Jinan, China."