Romosozumab followed by denosumab in Japanese women with high fracture risk in the FRAME trial
Romosozumab followed by denosumab in Japanese women with high fracture risk in the FRAME trial
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DOI：
10.1007/s00774-020-01147-5
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发表时间：
2020-10-15
影响因子：
3.3
通讯作者：
Shimauchi, Junichiro
中科院分区：
文献类型：
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作者：
Miyauchi, Akimitsu;Hamaya, Etsuro;Shimauchi, Junichiro
这项FRAME研究的事后分析调查了romosozumab和denosumab在绝经后日本骨质疏松症高骨折风险妇女中的长期疗效和安全性。材料和方法对参与国际随机、双盲、安慰剂对照的3期FRAME研究的日本高骨折风险女性的数据进行分析。高风险骨折定义为>= 1脆性骨折伴骨密度（BMD） 2常见椎体骨折，常见半定量3级椎体骨折或腰椎BMD < - 3.3 SD。终点包括12个月、24个月和36个月的新椎体骨折发生率，以及腰椎、全髋关节和股骨颈的骨密度与基线相比的百分比变化。结果187名日本高危骨折患者入组FRAME。在12个月、24个月和36个月时，romosozumab/denosumab与安慰剂/denosumab的新椎体骨折发生率较低（所有时间点的相对风险降低：84%；p = 0.056）。接受romosozumab/denosumab治疗的患者在12、24和36个月时的骨密度增加高于安慰剂/denosumab（腰椎：16.3%、21.5%和23.2% vs 0.4%、8.1%和10.4%；全髋关节：4.9%、7.9%和8.9% vs 0.4%、2.8%和4.1%；股骨颈：4.8%、7.6%和8.1% vs 0.3%、3.3%和3.7%；与安慰剂/denosumab相比，allp < 0.001）。不良事件在各组之间基本平衡。结论：与安慰剂/denosumab相比，Romosozumab/denosumab在所有测量的时间点上对骨折高风险的日本受试者产生了显著的BMD增加和数值上更低的椎体骨折率。
Introduction This post-hoc analysis of the FRAME study investigated the long-term efficacy and safety of romosozumab followed by denosumab in postmenopausal Japanese women with osteoporosis at high fracture risk. Materials and methods Data from Japanese women with a high fracture risk participating in the international, randomised, double-blind, placebo-controlled, phase 3 FRAME study were analysed. High risk of fracture was defined as >= 1 fragility fracture with bone mineral density (BMD) 2 prevalent vertebral fractures, prevalent semiquantitative grade 3 vertebral fracture, or lumbar spine BMD < - 3.3 SD. Endpoints included incidence of new vertebral fracture at 12, 24 and 36 months and percentage change from baseline in BMD at the lumbar spine, total hip and femoral neck. Results 187 Japanese subjects at high risk of fracture were enrolled in FRAME. Incidence of new vertebral fractures was lower with romosozumab/denosumab vs. placebo/denosumab at 12, 24 and 36 months (relative risk reduction at all timepoints: 84%;p = 0.056). BMD increases at 12, 24 and 36 months were greater in subjects receiving romosozumab/denosumab than placebo/denosumab (lumbar spine: 16.3%, 21.5% and 23.2% vs 0.4%, 8.1% and 10.4%; total hip: 4.9%, 7.9% and 8.9% vs 0.4%, 2.8% and 4.1%; femoral neck: 4.8%, 7.6% and 8.1% vs 0.3%, 3.3% and 3.7%, respectively; allp < 0.001 vs placebo/denosumab). Adverse events were generally balanced between groups. Conclusion Romosozumab/denosumab in Japanese subjects at high risk of fracture resulted in significant BMD gains and numerically lower vertebral fracture rate vs. placebo/denosumab at all timepoints measured.