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

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单位： [1]Department of Endocrinology, National Health Commission Key Laboratory of Endocrinology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China. [2]Department of Osteoporosis and Bone Disease, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China. [3]Department of Orthopaedics, Beijing Hospital, National Center of Gerontology, Beijing, China. [4]Department of Endocrinology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China. [5]Department of Endocrinology, Western Theater Command General Hospital, Chengdu, China. [6]Department of Endocrinology, The First Affiliated Hospital of Shanxi Medical University, Taiyuan, China. [7]Department of Osteoporosis and Bone Disease, Huadong Hospital Affiliated to Fudan University, Shanghai, China. [8]Department of Endocrinology and Metabolism, Shanghai General Hospital, Shanghai Jiao Tong University, 100 Haining Road, Shanghai, China. [9]Department of Orthopaedics, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, China. [10]Department of Orthopedics, Beijing Friendship Hospital, Capital Medical University, No. 95 Yong'an Road, Xicheng District, Beijing, China. [11]Department of Integrated of Traditional Chinese and Western Medicine, Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China. [12]Department of Endocrinology, Zhongshan Hospital, Fudan University, Shanghai, China. [13]Department of Obstetrics and Gynecology, The Second Affiliated Hospital of Soochow University, Soochow, China. [14]Department of Orthopaedics, Tianjin Hospital, Tianjin, China. [15]Department of Endocrinology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China. [16]Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, China. [17]Department of Orthopaedics, Heibei General Hospital, Zhengzhou, China. [18]Department of Endocrinology, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. [19]Department of Orthopedics Joint Disease Area, Chongqing Three Gorges Central Hospital, Chongqing, China. [20]Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China. [21]Department of Endocrinology, Key Laboratory of Endocrinology, NHC, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.

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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.To determine whether the efficacy of generic teriparatide is noninferior to alendronate for Chinese postmenopausal women with osteoporosis.Eligible patients were randomly assigned (2:1) in a 48-week, open-label design to receive 20 µg 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.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 β-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.Teriparatide was not inferior to alendronate in increasing BMD at lumbar spine in Chinese postmenopausal women, and they achieved these effects through different mechanisms.© 2022. The Author(s).

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出版当年[2021]版：

大类 | 3 区医学

小类 | 3 区骨科 4 区内分泌学与代谢

最新[2025]版：

大类 | 3 区医学

小类 | 3 区内分泌学与代谢 3 区骨科

JCR分区：

出版当年[2020]版：

Q2 ORTHOPEDICS Q4 ENDOCRINOLOGY & METABOLISM

最新[2023]版：

Q1 ORTHOPEDICS Q2 ENDOCRINOLOGY & METABOLISM

影响因子： 最新[2023版] 3.1 最新五年平均[2021-2025] 3 出版当年[2020版] 2.617 出版当年五年平均[2016-2020] 3.205 出版前一年[2019版] 2.017 出版后一年[2021版] 2.879

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第一作者单位： [1]Department of Endocrinology, National Health Commission Key Laboratory of Endocrinology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.

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