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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  期刊论文  

  • 编号：
    5ABD1F28A8CD4864CB018B3CC783ABAE
  • 作者：
    Zhang, Hao(张浩)#[1]Gu, JieMei(顾洁梅)#[1]Chao, AiJun[2];Cheng, Qun(程群)[3]Teng, DongHui[4];Yu, JinMing[5];Wang, BingWu[6];Huo, YaNan(霍亚南)[7]Mao, Li(毛莉)[8]Zhang, Qiu(章秋)[9]Yang, Hong[10];Yan, ShiGui(严世贵)[11]Zhang, KeQin(张克勤)[12]Zhao, XueLing(赵学凌)[13]Lin, Hua(林华)[14]Pei, Yu(裴育)[15]Yuan, Zhong[16];Dai, RuChun(戴如春)[17]He, Liang(贺良)[18]Chen, Li(陈丽)[19]Su, YongFeng[20];Deng, ZhongLiang(邓忠良)[21]You, Li(游利)[22]Ban, Bo(班博)[23]Zhu, Mei[24];Cao, YouLiang[25];Zhu, YiKun[26];Li, ZhiJun(李志军)[27]Zhang, Zhi[28];Yi, ChengQing(易诚青)[29]Lu, YiBing(鲁一兵)[30]Wang, Guang(王广)[31]Han, CuiCui[32];Wang, ZhenJiang[33];Li, XianXing[34];Zhang, ZhenLin(章振林)*[1]
  • 语种：
    英文
  • 期刊：
    ACTA PHARMACOLOGICA SINICA ISSN：1671-4083 2023 年 44 卷 2 期 (446 - 453) ; FEB
  • 收录：
     
  • 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.

  • 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.
  • APA：
    Zhang Hao,Gu Jie-Mei,Chao Ai-Jun,Cheng Qun,&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):446-453.
  • 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.
  • 入库时间：
    2022/8/13 21:48:15
  • 更新时间：
    2022/8/13 21:48:15
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