Dhaliwal Ruban, Hans Didier, Hattersley Gary, Mitlak Bruce, Fitzpatrick Lorraine A, Wang Yamei, Schwartz Ann V, Miller Paul D, Josse Robert G
Metabolic Bone Disease Center State University of New York Upstate Medical University Syracuse NY USA.
Center of Bone Disease, Bones & Joints Department Lausanne University Hospital Lausanne Switzerland.
JBMR Plus. 2020 Feb 27;4(4):e10346. doi: 10.1002/jbm4.10346. eCollection 2020 Apr.
Type 2 diabetes mellitus (T2DM) increases fracture risk despite normal or increased BMD. Abaloparatide reduces fracture risk in patients with postmenopausal osteoporosis (PMO); however, its efficacy in women with T2DM is unknown. This post hoc analysis evaluated the efficacy and safety of abaloparatide in patients with T2DM. The analysis included patients with T2DM from the baloparatide omparator rial n ertebral ndpoints (ACTIVE), a phase 3, double-blind, randomized, placebo- and active-controlled trial. In ACTIVE, participants were randomized 1:1:1 to daily s.c. injections of placebo, abaloparatide (80 μg), or open-label teriparatide (20 μg) for 18 months. A total of 198 women with PMO and T2DM from 21 centers in 10 countries were identified from ACTIVE through review of their medical records. The main outcomes measured included effect of abaloparatide versus placebo on BMD and trabecular bone score (TBS), with secondary outcomes of fracture risk and safety, in patients from ACTIVE with T2DM. Significant ( < 0.001) improvements in BMD at total hip (mean change 3.0% versus -0.4%), femoral neck (2.6% versus -0.2%), and lumbar spine (8.9% versus 1.3%) and TBS at lumbar spine (3.72% versus -0.56%) were observed with abaloparatide versus placebo at 18 months. Fracture events were fewer with abaloparatide treatment in patients with T2DM, and differences were not significant between groups except nonvertebral fractures in the abaloparatide versus placebo groups ( = 0.04). Safety was consistent with the ACTIVE population. In conclusion, in women with PMO and T2DM, abaloparatide treatment resulted in significant improvements in BMD and TBS versus placebo, consistent with the overall ACTIVE population © 2020 The Authors. published by Wiley Periodicals, Inc. on behalf of American Society for Bone and Mineral Research.
2型糖尿病（T2DM）即便骨密度正常或升高，骨折风险也会增加。阿巴洛肽可降低绝经后骨质疏松症（PMO）患者的骨折风险；然而，其对T2DM女性患者的疗效尚不清楚。这项事后分析评估了阿巴洛肽对T2DM患者的疗效和安全性。该分析纳入了来自阿巴洛肽比较脊柱终点试验（ACTIVE）的T2DM患者，这是一项3期、双盲、随机、安慰剂对照和活性药物对照试验。在ACTIVE试验中，参与者按1:1:1随机分组，每日皮下注射安慰剂、阿巴洛肽（80μg）或开放标签的特立帕肽（20μg），为期18个月。通过查阅病历，从ACTIVE试验中识别出了来自10个国家21个中心的198例患有PMO和T2DM的女性。主要测量结果包括在ACTIVE试验中患有T2DM的患者中，阿巴洛肽与安慰剂相比对骨密度和小梁骨评分（TBS）的影响，次要结果为骨折风险和安全性。在18个月时，与安慰剂相比，阿巴洛肽治疗使全髋骨密度（平均变化3.0%对-0.4%）、股骨颈骨密度（2.6%对-0.2%）和腰椎骨密度（8.9%对1.3%）以及腰椎TBS（3.72%对-0.56%）有显著（<0.001）改善。T2DM患者接受阿巴洛肽治疗的骨折事件较少，除阿巴洛肽组与安慰剂组的非椎体骨折外（P=0.04），各治疗组间差异无统计学意义。安全性与ACTIVE试验总体人群一致。总之，在患有PMO和T2DM的女性中，与安慰剂相比，阿巴洛肽治疗使骨密度和TBS有显著改善，这与ACTIVE试验总体人群一致。©2020作者。由Wiley Periodicals, Inc.代表美国骨与矿物质研究学会出版。
