Efficacy of generic teriparatide and alendronate in Chinese postmenopausal women with osteoporosis: a prospective study

作者全名："Li, Mei; Zhang, Zhenlin; Xue, Qingyun; Li, Qifu; Jin, Xiaolan; Dong, Jin; Cheng, Qun; You, Li; Lin, Hua; Tang, Hai; Shen, Lin; Gao, Xin; Hu, Ji; Chao, Aijun; Li, Pengqiu; Shi, Rui; Zheng, Shuhui; Zhang, Ying; Xiong, Xiaojiang; Yu, Wei; Xia, Weibo"

作者地址："[Li, Mei] Chinese Acad Med Sci, Peking Union Med Coll Hosp, Dept Endocrinol, Natl Hlth Commiss Key Lab Endocrinol, Beijing, Peoples R China; [Zhang, Zhenlin] Shanghai Jiao Tong Univ, Dept Osteoporosis & Bone Dis, Affiliated Peoples Hosp 6, Shanghai, Peoples R China; [Xue, Qingyun] Beijing Hosp, Natl Ctr Gerontol, Dept Orthopaed, Beijing, Peoples R China; [Li, Qifu] Chongqing Med Univ, Dept Endocrinol, Affiliated Hosp 1, Chongqing, Peoples R China; [Jin, Xiaolan] Western Theater Command Gen Hosp, Dept Endocrinol, Chengdu, Peoples R China; [Dong, Jin] Shanxi Med Univ, Dept Endocrinol, Affiliated Hosp 1, Taiyuan, Peoples R China; [Cheng, Qun] Fudan Univ, Dept Osteoporosis & Bone Dis, Huadong Hosp, Shanghai, Peoples R China; [You, Li] Shanghai Jiao Tong Univ, Shanghai Gen Hosp, Dept Endocrinol & Metab, 100 Haining Rd, Shanghai, Peoples R China; [Lin, Hua] Nanjing Univ, Dept Orthopaed, Affiliated Hosp, Nanjing Drum Tower Hosp,Med Sch, Nanjing, Peoples R China; [Tang, Hai] Capital Med Univ, Beijing Friendship Hosp, Dept Orthoped, 95 Yongan Rd, Beijing, Peoples R China; [Shen, Lin] Huazhong Univ Sci & Technol, Union Hosp, Dept Integrated Tradit Chinese & Western Med, Tongji Med Coll, Wuhan, Peoples R China; [Gao, Xin] Fudan Univ, Zhongshan Hosp, Dept Endocrinol, Shanghai, Peoples R China; [Hu, Ji] Soochow Univ, Dept Obstet & Gynecol, Affiliated Hosp 2, Suzhou, Peoples R China; [Chao, Aijun] Tianjin Hosp, Dept Orthopaed, Tianjin, Peoples R China; [Li, Pengqiu] Sichuan Acad Med Sci & Sichuan Prov Peoples Hosp, Dept Endocrinol, Chengdu, Peoples R China; [Shi, Rui] Sichuan Univ, West China Hosp, Dept Orthoped, Chengdu, Peoples R China; [Zheng, Shuhui] Heibei Gen Hosp, Dept Orthopaed, Zhengzhou, Peoples R China; [Zhang, Ying] Guangzhou Med Univ, Dept Endocrinol, Affiliated Hosp 3, Guangzhou, Peoples R China; [Xiong, Xiaojiang] Chongqing Three Gorges Cent Hosp, Dept Orthoped Joint Dis Area, Chongqing, Peoples R China; [Yu, Wei] Chinese Acad Med Sci, Peking Union Med Coll Hosp, Dept Radiol, Beijing, Peoples R China; [Xia, Weibo] Chinese Acad Med Sci, Peking Union Med Coll Hosp, Dept Endocrinol,NHC, Key Lab Endocrinol,State Key Lab Complex Severe &, Beijing, Peoples R China"

通信作者："Xia, WB (通讯作者)，Chinese Acad Med Sci, Peking Union Med Coll Hosp, Dept Endocrinol,NHC, Key Lab Endocrinol,State Key Lab Complex Severe &, Beijing, Peoples R China."

来源：ARCHIVES OF OSTEOPOROSIS

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:000832714600001

JCR分区：Q2

影响因子：3

年份：2022

卷号：17

期号：1

开始页：　

结束页：　

文献类型：Article

关键词：Teriparatide; Alendronate; Postmenopausal osteoporosis; Bone mineral density; Bone turnover markers

摘要："The efficacy of generic teriparatide in improving BMD at lumbar spine in patients with osteoporosis was similar to that of alendronate. It provided a new choice for osteoporosis treatment in Chinese population. Introduction To determine whether the efficacy of generic teriparatide is noninferior to alendronate for Chinese postmenopausal women with osteoporosis. Methods Eligible patients were randomly assigned (2:1) in a 48-week, open-label design to receive 20 mu g sc daily teriparatide or 70 mg oral weekly alendronate. Primary outcome was percentage change in BMD at the lumbar spine from baseline to 48 weeks and was assessed for non-inferiority. The same outcome was further assessed for superiority as a secondary endpoint. Results Three hundred ninety-one and 196 participants were randomly assigned to the teriparatide or alendronate group, of whom 379 and 194 receiving at least one dose of teriparatide and alendronate treatment were eligible for the efficacy analysis. Teriparatide was non-inferior to alendronate for BMD change at lumbar spine (treatment difference: 0.7%, 95% CI: - 0.3 to 1.7%), which excluded the predefined non-inferiority margin of - 1.5%. However, teriparatide was not statistically superior to alendronate in improving BMD at lumbar spine (P = 0.169). At 48 weeks, changes in BMD at total hip were - 1.0% and 2.2% in teriparatide and alendronate group, respectively (P < 0.001). The incidence of new fracture showed no statistical difference between groups (P = 0.128). Serum P1NP and beta-CTX levels significantly increased in the teriparatide group and markedly decreased in alendronate group (all P < 0.001 vs baseline). The adverse events (AEs) and serious AEs were more common in the teriparatide group than in the alendronate group, which were mainly teriparatide-related hypercalcemia, elevated alkaline phosphatase or parathyroid hormone, dizziness, and arthralgia. Conclusions Teriparatide was not inferior to alendronate in increasing BMD at lumbar spine in Chinese postmenopausal women, and they achieved these effects through different mechanisms."

基金机构："Suzhou Jinmeng Biotechnology Co., Ltd, China"

基金资助正文："This study was supported by Suzhou Jinmeng Biotechnology Co., Ltd, China."