Bone Turnover Markers Predict Changes in Bone Mineral Density in Men Treated with Abaloparatide: Results from ATOM.

IF 5.1 1区 医学 Q1 ENDOCRINOLOGY & METABOLISM
Richard Eastell, Jacques P Brown, Robert A Adler, E Michael Lewiecki, Neil Binkley, Eric S Orwoll, David Kendler, Bruce H Mitlak, Yamei Wang
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引用次数: 0

Abstract

Early increases in bone turnover markers (BTMs) in response to anabolic therapy correlate with 18-month bone mineral density (BMD) increases in postmenopausal women with osteoporosis; however, this relationship has not been assessed in men. In this analysis, the correlation between changes from baseline in fasting intact serum procollagen type I N propeptide (PINP) and serum carboxy-terminal cross-linking telopeptide of type I collagen (CTX) at 1, 3, 6, and 12 months and percent increase from baseline in BMD at 12 months in men from the randomized phase 3 ATOM study (NCT03512262) were evaluated using Pearson's correlation coefficients. The uncoupling index (UI), a measure of the balance between markers of bone formation (PINP) and bone resorption (CTX), with positive UI favoring bone formation, was calculated. Results in men were compared to 12-month results for women from the ACTIVE study using the z score test after Fisher's Z transformation. In abaloparatide-treated men, PINP increases at 1 month (r = 0.485), 3 months (r = 0.614), 6 months (r = 0.632), and 12 months (r = 0.521) were highly correlated (P<.0001) with 12-month lumbar spine BMD increases. The mean UI for abaloparatide-treated men was greater than placebo as early as 1 month (2.26 versus -0.25). At month 3, the mean UI for men was greater (1.32) than for women (0.88) (P<.001). There was a significant correlation between 3-month UI and lumbar spine BMD at 12 months in both men (r = 0.453; P<.001) and women (r = 0.252; P<.01); UI at months 6 and 12 were also significantly correlated with 12-month lumbar spine BMD in men and women, but the correlation was stronger in men than women. These data support that early changes in BTMs in men treated with abaloparatide are associated with subsequent changes in BMD similar to what has been reported in women. Trial registration: clinicaltrials.gov Identifier NCT03512262.

骨转换标志物预测阿巴巴拉肽治疗的男性骨密度的变化:ATOM的结果。
绝经后骨质疏松症妇女接受合成代谢治疗后早期骨转换标志物(BTMs)升高与18个月骨密度(BMD)升高相关然而,这种关系尚未在男性中得到评估。在本分析中,使用Pearson相关系数评估随机3期ATOM研究(NCT03512262)的男性患者在1、3、6和12个月时空腹完整血清I型胶原N前肽(PINP)和血清I型胶原羧基末端交联末端肽(CTX)的基线变化与12个月时骨密度比基线增加的百分比之间的相关性。解耦指数(uncoupling index, UI)是衡量骨形成标志物(PINP)和骨吸收标志物(CTX)之间平衡的指标,UI为正有利于骨形成。在Fisher的z转换后,使用z分数测试将男性的结果与ACTIVE研究中女性12个月的结果进行比较。在鲍巴肽治疗的男性中,PINP增高在1个月(r = 0.485)、3个月(r = 0.614)、6个月(r = 0.632)和12个月(r = 0.521)高度相关(P < 0.05)
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来源期刊
Journal of Bone and Mineral Research
Journal of Bone and Mineral Research 医学-内分泌学与代谢
CiteScore
11.30
自引率
6.50%
发文量
257
审稿时长
2 months
期刊介绍: The Journal of Bone and Mineral Research (JBMR) publishes highly impactful original manuscripts, reviews, and special articles on basic, translational and clinical investigations relevant to the musculoskeletal system and mineral metabolism. Specifically, the journal is interested in original research on the biology and physiology of skeletal tissues, interdisciplinary research spanning the musculoskeletal and other systems, including but not limited to immunology, hematology, energy metabolism, cancer biology, and neurology, and systems biology topics using large scale “-omics” approaches. The journal welcomes clinical research on the pathophysiology, treatment and prevention of osteoporosis and fractures, as well as sarcopenia, disorders of bone and mineral metabolism, and rare or genetically determined bone diseases.
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