Bone and Joint Surgery, Seirei Hamamatsu General Hospital, Shizuoka, Japan.
School of Health Science, Faculty of Medicine, Tottori University, Tottori, Japan.
Osteoporos Int. 2023 Jan;34(1):189-199. doi: 10.1007/s00198-022-06570-0. Epub 2022 Oct 14.
In this randomized, controlled trial, sequential therapy with once-weekly subcutaneous injection of teriparatide for 72 weeks, followed by alendronate for 48 weeks resulted in a significantly lower incidence of morphometric vertebral fracture than monotherapy with alendronate for 120 weeks in women with osteoporosis at high risk of fracture.
To determine whether the anti-fracture efficacy of sequential therapy with teriparatide, followed by alendronate is superior to that of monotherapy with 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 if they were at high risk of fracture. Patients were randomly assigned (1:1) to receive the 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 in the final analysis was the incidence of morphometric vertebral fracture during the 120-week follow-up period.
Between October 2014 and June 2020, 505 patients in the sequential therapy group and 506 in the monotherapy group were enrolled. Of these, 489 and 496, respectively, were included in the main analysis. The incidence of morphometric vertebral fracture during the 120-week follow-up period in the sequential therapy group (64 per 627.5 person-years, annual incidence rate 0.1020) was significantly lower than that in the monotherapy group (126 per 844.2 person-years, annual incidence rate 0.1492), with a rate ratio of 0.69 (95% confidence interval 0.54 to 0.88, P < 0.01). After 72 weeks, no patient had a severe adverse event that was considered related to the study drug.
Once-weekly injection of teriparatide, followed by alendronate resulted in a significantly lower incidence of morphometric vertebral fracture than alendronate monotherapy in women with osteoporosis who were at high risk of fracture. TRIAL REGISTRATION NUMBER, DATE OF REGISTRATION: jRCTs031180235 and UMIN000015573, March 12, 2019.
在这项随机对照试验中，每周一次皮下注射特立帕肽 72 周，随后用阿仑膦酸钠治疗 48 周，与阿仑膦酸钠治疗 120 周相比，显著降低了高骨折风险骨质疏松症女性的形态计量椎体骨折发生率。
为了确定特立帕肽序贯治疗联合阿仑膦酸钠是否优于阿仑膦酸钠单药治疗，我们进行了一项前瞻性、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有高骨折风险，则有资格参加这项研究。患者被随机分配（1:1）接受序贯治疗（每周一次皮下注射特立帕肽 56.5 μg 72 周，随后用阿仑膦酸钠治疗 48 周）或阿仑膦酸钠单药治疗 120 周。最终分析中的主要终点是 120 周随访期间形态计量椎体骨折的发生率。
2014 年 10 月至 2020 年 6 月，505 例患者入组序贯治疗组，506 例患者入组阿仑膦酸钠组。其中，分别有 489 例和 496 例患者纳入主要分析。在 120 周的随访期间，序贯治疗组形态计量椎体骨折的发生率（64 例/627.5 人年，年发生率 0.1020）明显低于阿仑膦酸钠组（126 例/844.2 人年，年发生率 0.1492），比率为 0.69（95%置信区间 0.54 至 0.88，P<0.01）。在 72 周后，没有患者出现被认为与研究药物相关的严重不良事件。
在高骨折风险的骨质疏松症女性中，每周一次注射特立帕肽，随后用阿仑膦酸钠治疗，与阿仑膦酸钠单药治疗相比，形态计量椎体骨折的发生率显著降低。
试验注册号、注册日期：jRCTs031180235 和 UMIN000015573，2019 年 3 月 12 日。
