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从特立帕肽转换为双膦酸盐或地诺单抗的疗效:一项前瞻性、随机、开放标签试验。

Efficacy of Switching From Teriparatide to Bisphosphonate or Denosumab: A Prospective, Randomized, Open-Label Trial.

作者信息

Niimi Rui, Kono Toshibumi, Nishihara Atsushi, Hasegawa Masahiro, Kono Toshihiko, Sudo Akihiro

机构信息

Department of Orthopaedic Surgery Tomidahama Hospital Mie Japan.

Department of Orthopaedic Surgery Mie University Graduate School of Medicine Mie Japan.

出版信息

JBMR Plus. 2018 Jun 2;2(5):289-294. doi: 10.1002/jbm4.10054. eCollection 2018 Sep.

Abstract

There is no consensus on an optimal treatment after daily teriparatide (TPTD). We performed a prospective, randomized, open-label, 12-month trial to investigate the efficacy of follow-up treatment after daily TPTD treatment for Japanese patients. Three-hundred patients were enrolled in this study. Patients received oral bisphosphonate (BP) including alendronate (ALN; 35 mg/week) and minodoronate (MINO; 50 mg/month), or subcutaneous denosumab (60 mg/6 month). The primary efficacy measure was bone mineral density (BMD) responses in the lumbar spine (LS) and femoral neck (FN). Lumbar spine BMD increased by 1.3 ± 5.1% in the ALN subgroups, 0.5 ± 4.6% in the MINO subgroups, and 4.3 ± 3.5% in the denosumab subgroups. Femoral neck BMD increased by 0.7 ± 4.6% in the ALN subgroups, 0.2 ± 4.6% in the MINO subgroups, and 1.4 ± 3.4% in the denosumab subgroups. Lumbar spine BMD increases were significantly greater in the denosumab subgroup than the BP subgroups. There were no significant differences in FN BMD increases among the three subgroups. Lumbar spine BMD increases were significantly greater in the denosumab subgroup than the BP subgroups, whereas FN BMD increases were not significant. Denosumab treatment was more effective in increasing BMD and therefore has the potential benefit of fracture prevention. Further research is warranted to determine the optimal treatment after daily TPTD. © 2018 The Authors. published by Wiley Periodicals, Inc. on behalf of American Society for Bone and Mineral Research.

摘要

对于每日一次使用特立帕肽(TPTD)后的最佳治疗方案,目前尚无共识。我们进行了一项前瞻性、随机、开放标签的12个月试验,以研究日本患者每日一次TPTD治疗后后续治疗的疗效。本研究共纳入300例患者。患者接受口服双膦酸盐(BP),包括阿仑膦酸钠(ALN;35mg/周)和米诺膦酸(MINO;50mg/月),或皮下注射地诺单抗(60mg/6个月)。主要疗效指标是腰椎(LS)和股骨颈(FN)的骨密度(BMD)反应。在ALN亚组中,腰椎BMD增加了1.3±5.1%,在MINO亚组中增加了0.5±4.6%,在地诺单抗亚组中增加了4.3±3.5%。在ALN亚组中,股骨颈BMD增加了0.7±4.6%,在MINO亚组中增加了0.2±4.6%,在地诺单抗亚组中增加了1.4±3.4%。地诺单抗亚组的腰椎BMD增加显著高于BP亚组。三个亚组之间股骨颈BMD增加无显著差异。地诺单抗亚组的腰椎BMD增加显著高于BP亚组,而股骨颈BMD增加不显著。地诺单抗治疗在增加BMD方面更有效,因此具有预防骨折的潜在益处。有必要进行进一步研究以确定每日一次TPTD后的最佳治疗方案。©2018作者。由Wiley Periodicals, Inc.代表美国骨与矿物质研究学会出版。

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