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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

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收录情况： ◇ SCIE ◇ 统计源期刊 ◇ CSCD-C ◇ 卓越：重点期刊

作者：
Zhang Hao[1] * ; Gu Jie-Mei[1] * ; Chao Ai-Jun[2] ; Cheng Qun[3] ; Teng Dong-Hui[4] ; Yu Jin-Ming[5] ; Wang Bing-Wu[6] ; Huo Ya-Nan[7] ; Mao Li[8] ; Zhang Qiu[9] ; Yang Hong[10] ; Yan Shi-Gui[11] ; Zhang Ke-Qin[12] ; Zhao Xue-Ling[13] ; Lin Hua[14] ; Pei Yu[15] ; Yuan Zhong[16] ; Dai Ru-Chun[17] ; He Liang[18] ; Chen Li[19] ; Su Yong-Feng[20] ; Deng Zhong-Liang[21] ; You Li[22] ; Ban Bo[23] ; Zhu Mei[24] ; Cao You-Liang[25] ; Zhu Yi-Kun[26] ; Li Zhi-Jun[27] ; Zhang Zhi[28] ; Yi Cheng-Qing[29] ; Lu Yi-Bing[30] ; Wang Guang[31] ; Han Cui-Cui[32] ; Wang Zhen-Jiang[33] ; Li Xian-Xing[34] ; Zhang Zhen-Lin[35] ;
机构： [1]Department of Osteoporosis and Bone Diseases, Shanghai Clinical Research Center of Bone Diseases, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 200233, China. [2]Department of Osteo-Internal, Tianjin Hospital, Tianjin, 300211, China. [3]Department of Osteoporosis, Huadong Hospital Affiliated to Fudan University, Shanghai, 200040, China. [4]Department of Orthopedics, Tianjin First Central Hospital, Tianjin, 300192, China. [5]Department of Endocrinology, The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, 530016, China. [6]Department of Spine Surgery, Weifang People's Hospital, Weifang, 261000, China. [7]Department of Endocrinology, Jiangxi Provincial People's Hospital Affiliated to Nanchang University, Nanchang, 330006, China. [8]Department of Endocrinology, The Affiliated Huaian No. 1 People's Hospital of Nanjing Medical University, Huaian, 223300, China. [9]Department of Endocrinology, The First Affillated Hospital of Anhui Medical University, Hefei, 230022, China. [10]Department of Endocrinology, Ruian People's Hospital, Wenzhou, 325200, China. [11]Department of Orthopedics, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, 310009, China. [12]Department of Endocrinology, Tongji Hospital of Tongji University, Shanghai, 200065, China. [13]Department of Orthopedics, First Affillated Hospital of Kunming Medical University, Kunming, 650032, China. [14]Metabolic Bone Disease Prevention and Treatment Research Center, Nanjing Drum Tower Hospital, Nanjing, 210008, China. [15]Department of Endocrinology, Chinese PLA General Hospital, Beijing, 100853, China. [16]Department of Osteoporosis, Nanchang Hongdu Hospital of TCM, Nanchang, 330006, China. [17]Department of Endocrinology, The Second Xiangya Hospital of Central South University, Changsha, 410011, China. [18]Department of Orthopedics, Beijing Jishuitan Hospital, Beijing, 100035, China. [19]Department of Endocrinology, Qilu Hospital of Shandong University, Jinan, 250012, China. [20]Department of Endocrinology, Inner Mongolia Baogang Hospital, Baotou, 014010, China. [21]Department of Spine Surgery, The second affiliated hospital of Chongqing medical university, Chongqing, 400010, China. [22]Department of Endocrinology, Shanghai General Hospital, Shanghai Jiaotong University, Shanghai, 200080, China. [23]Department of Endocrinology, Affiliated Hospital of Jining Medical University, Jining, 272007, China. [24]Department of Endocrinology, Tianjin Medical University General Hospital, Tianjin, 300052, China. [25]Department of Orthopedics, The Third People's Hospital of Yunnan Province, Kunming, 650011, China. [26]Department of Endocrinology, Second Hospital of Shanxi Medical University, Taiyuan, 030001, China. [27]Department of Rheumatology and Immunology, The First Affillated Hospital of Bengbu Medical College, Bengbu, 233004, China. [28]Department of Spine Surgery, Suining Central Hospital, Suining, 629000, China. [29]Department of Orthopedics, Shanghai Pudong Hospital, Shanghai, 201399, China. [30]Department of Endocrinology, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, 210011, China. [31]Department of Endocrinology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, 100020, China. [32]Department of Medical, Qilu Pharmaceutical Co., Ltd, Jinan, 250100, China. [33]Department of Project, Qilu Pharmaceutical Co., Ltd, Jinan, 250100, China. [34]Department of Statistical analysis, Qilu Pharmaceutical Co., Ltd, Jinan, 250100, China. [35]Department of Osteoporosis and Bone Diseases, Shanghai Clinical Research Center of Bone Diseases, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 200233, China. zhangzl@sjtu.edu.cn.
出处：
DOI： 10.1038/s41401-022-00954-y
ISSN：

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.© 2022. The Author(s), under exclusive licence to Shanghai Institute of Materia Medica, Chinese Academy of Sciences and Chinese Pharmacological Society.

基金：
Qilu Pharmaceutical Co. Ltd, Jinan, China
语种：
外文
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出版当年[2024]版：
无
最新[2023]版：
大类 | 1 区 医学
小类 | 1 区 药学 2 区 化学：综合
JCR分区：
出版当年[2023]版：
Q1 CHEMISTRY, MULTIDISCIPLINARY Q1 PHARMACOLOGY & PHARMACY
最新[2023]版：
Q1 CHEMISTRY, MULTIDISCIPLINARY Q1 PHARMACOLOGY & PHARMACY

影响因子： 最新[2023版] 最新五年平均 出版当年[2023版] 出版当年五年平均 出版前一年[2022版]

第一作者：
第一作者机构： [1]Department of Osteoporosis and Bone Diseases, Shanghai Clinical Research Center of Bone Diseases, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 200233, China.
共同第一作者：
通讯作者：
推荐引用方式(GB/T 7714)：
Zhang Hao,Gu Jie-Mei,Chao Ai-Jun,et al.A phase III randomized, double-blind, placebo-controlled trial of the denosumab biosimilar QL1206 in postmenopausal Chinese women with osteoporosis and high fracture risk[J].ACTA PHARMACOLOGICA SINICA.2023,44(2):446-453.doi:10.1038/s41401-022-00954-y.
APA：
Zhang Hao,Gu Jie-Mei,Chao Ai-Jun,Cheng Qun,Teng Dong-Hui...&Zhang Zhen-Lin.(2023).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,44,(2)
MLA：
Zhang Hao,et al."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 44..2(2023):446-453

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