School of Health Science, Tottori University Faculty of Medicine, Yonago, Tottori, Japan.
Eikokai Ono Hospital, 973 Tenjin-cho, Ono, Hyogo, Japan.
Osteoporos Int. 2021 Nov;32(11):2301-2311. doi: 10.1007/s00198-021-05996-2. Epub 2021 May 17.
In this randomized, controlled trial, treatment with once-weekly subcutaneous injection of teriparatide for 72 weeks was found to be associated with a significant reduction in the incidence of morphometric vertebral fractures compared with alendronate in women with primary osteoporosis who were at high risk of fracture.
To determine whether the anti-fracture efficacy of teriparatide is superior to that of alendronate, a prospective, randomized, open-label, blinded-endpoint trial was performed.
Japanese women aged at least 75 years were eligible for the study if they had primary osteoporosis and were at high risk of fracture. Patients were randomly assigned in a 1:1 ratio to receive sequential therapy (once-weekly subcutaneous injection of teriparatide 56.5 μg for 72 weeks followed by alendronate for 48 weeks) or monotherapy with alendronate for 120 weeks. The primary endpoint was the incidence of morphometric vertebral fractures at 72 weeks (at the end of teriparatide treatment).
Between October 2014 and December 2017, 1011 patients (505 in the teriparatide group and 506 in the alendronate group) were enrolled. Of these, 778 patients (351 and 427, respectively) were included in the primary analysis. The incidence of morphometric vertebral fractures was significantly lower in the teriparatide group (56 per 419.9 person-years, annual incidence rate 0.1334) than in the alendronate group (96 per 553.6 person-years, annual incidence rate 0.1734), with a rate ratio of 0.78 (95% confidence interval 0.61 to 0.99, P = 0.04). In both groups, adverse events were most frequently reported in the following system organ classes: infections and infestations, gastrointestinal disorders, and musculoskeletal and connective tissue disorders.
Once-weekly subcutaneous injection of teriparatide significantly reduced the incidence of morphometric vertebral fractures compared with alendronate in women with primary osteoporosis who were at high risk of fracture.
jRCTs031180235 and UMIN000015573, March 12, 2019.
为了确定特立帕肽的抗骨折疗效是否优于阿仑膦酸钠，进行了一项前瞻性、随机、开放标签、盲终点试验。
年龄至少 75 岁的日本女性，如果患有原发性骨质疏松症且骨折风险高，则有资格参加这项研究。患者按 1:1 的比例随机分配，接受序贯治疗（72 周内每周一次皮下注射特立帕肽 56.5 μg，然后再接受阿仑膦酸钠治疗 48 周）或阿仑膦酸钠单药治疗 120 周。主要终点是 72 周（特立帕肽治疗结束时）的形态计量椎体骨折发生率。
2014 年 10 月至 2017 年 12 月，共纳入 1011 例患者（特立帕肽组 505 例，阿仑膦酸钠组 506 例）。其中，778 例患者（特立帕肽组 351 例，阿仑膦酸钠组 427 例）被纳入主要分析。特立帕肽组形态计量椎体骨折的发生率明显低于阿仑膦酸钠组（56 例/419.9 人年，年发生率 0.1334），率比为 0.78（95%置信区间 0.61 至 0.99，P=0.04）。在两组中，最常报告的不良事件发生在以下系统器官类别：感染和寄生虫感染、胃肠道疾病以及肌肉骨骼和结缔组织疾病。
与阿仑膦酸钠相比，每周一次皮下注射特立帕肽可显著降低骨折高风险的原发性骨质疏松症女性的形态计量椎体骨折发生率。
jRCTs031180235 和 UMIN000015573，2019 年 3 月 12 日。
