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

作者：Mei Li, Zhenlin Zhang, Qingyun Xue, Qifu Li, Xiaolan Jin, Jin Song Dong, Qun Cheng, You Li, Hua Lin, Hai Tang, Lin Shen, Xin Gao, Ji Hu, Aijun Chao, Pengqiu Li, Rui Shi, Shuhui Zheng, Ying Zhang, Xiaojiang Xiong, Wei Yu, Weibo Xia · 发表于：Archives of Osteoporosis · 年份：2022 · DOI：10.1007/s11657-022-01131-8 · 被引用次数：26 · 研究领域：Bone health and osteoporosis research、Bone health and treatments、Bone Metabolism and Diseases

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 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. 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 ...