阿巴帕肽治疗男性腰椎、全髋和股骨颈骨矿物质密度的应答率:ATOM 研究的结果。

IF 3.4 Q2 ENDOCRINOLOGY & METABOLISM
JBMR Plus Pub Date : 2024-01-27 eCollection Date: 2024-02-01 DOI:10.1093/jbmrpl/ziae009
Ruban Dhaliwal, David Kendler, Kenneth Saag, Steven W Ing, Andrea Singer, Robert A Adler, Leny Pearman, Yamei Wang, Bruce Mitlak
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引用次数: 0

摘要

男性骨质疏松症是一个未得到充分重视的公共健康问题,约占骨质疏松症社会负担的 30%。虽然男性骨质疏松症的发病率较低,但与骨折相关的发病率和死亡率却超过了女性。阿巴帕肽是一种合成的 34 氨基酸肽,与人类甲状旁腺激素相关蛋白(PTHrP)具有同源性,可通过选择性激活 PTH 受体 1 型来促进骨形成。在阿巴拉帕肽治疗男性骨质疏松症(ATOM;NCT03512262)试验中,228名患有原发性或性腺功能低下相关性骨质疏松症的男性被随机分配接受阿巴拉帕肽80微克或安慰剂的皮下注射。与安慰剂相比,阿巴拉帕肽能明显改善LS、TH和FN BMD。在这项预设分析中,比较了 ATOM 中阿巴帕肽组与安慰剂组之间在 3、6 和 12 个月时 LS、TH 和 FN BMD 与基线相比变化百分比大于 0%、大于 3% 和大于 6% 的男性比例,以及/或在 12 个月时 T 评分类别发生变化(基于 LS 和 TH T 评分)的男性比例。在第 6 个月时(18/122 [14.8%] vs 1/70 [1.4%],P = .002)和第 12 个月时(38/119 [31.9%] vs 1/66 [1.5%],P 3%),阿巴帕肽组在所有 3 个解剖部位的 BMD 增幅均大于安慰剂组的男性人数(82/134 [61.2%] vs 21/68 [30.9%],P = .002)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Response rates for lumbar spine, total hip, and femoral neck bone mineral density in men treated with abaloparatide: results from the ATOM study.

Osteoporosis in men is an underappreciated public health issue, accounting for approximately 30% of the societal burden of osteoporosis. Although the prevalence of osteoporosis in men is lower, fracture-related morbidity and mortality rates exceed those of women. Abaloparatide is a synthetic, 34-amino acid peptide with homology to human parathyroid hormone-related protein (PTHrP), which favors bone formation by selective activation of PTH receptor type 1. In the Abaloparatide for the Treatment of Men With Osteoporosis (ATOM; NCT03512262) trial, 228 men with primary or hypogonadism-associated osteoporosis were randomized to receive subcutaneous injections of abaloparatide 80 μg or placebo. Abaloparatide significantly improved LS, TH, and FN BMD when compared with placebo. In this prespecified analysis, the proportion of men with a percent change from baseline of >0%, >3%, and > 6% in BMD at the LS, TH, and FN at 3, 6, and 12 mo and/or a shift in T-score category (based on LS and TH T-scores) at 12 mo was compared between the abaloparatide and placebo groups in ATOM. There were significantly more men with a BMD gain of >3% at all 3 anatomical sites in the abaloparatide than placebo group at month 6 (18/122 [14.8%] vs 1/70 [1.4%], P = .002) and at month 12 (38/119 [31.9%] vs 1/66 [1.5%], P < .0001). At month 3, more men treated with abaloparatide than placebo had a > 3% BMD increase at the LS (82/134 [61.2%] vs 21/68 [30.9%], P < .0001). A greater proportion of men treated with abaloparatide had an improvement in T-score category from osteoporosis to low BMD or normal when compared with placebo. In conclusion, use of abaloparatide compared with placebo for 12 mo resulted in significant and rapid improvements in BMD in men with osteoporosis from the ATOM study.

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来源期刊
JBMR Plus
JBMR Plus Medicine-Orthopedics and Sports Medicine
CiteScore
5.80
自引率
2.60%
发文量
103
审稿时长
8 weeks
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