Combined baseline P1NP and TRAcP5b classification predicts differential bone mineral density response to romosozumab: A retrospective cohort study of 287 postmenopausal women

IF 2.5 4区医学 Q4 ENDOCRINOLOGY & METABOLISM

Journal of Clinical Densitometry Pub Date : 2026-10-01 Epub Date: 2026-09-16 DOI:10.1016/j.jocd.2026.101747

Ryo Nakano, Ayumi Ichisawa, Kenya Saruta, Masakazu Kogawa, Akira Fukuda

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引用次数: 0

Abstract

Introduction Individual bone turnover markers predict bone mineral density response to romosozumab; however, their combined assessment has not been evaluated. We investigated whether a simple classification based on baseline procollagen type I N-terminal propeptide and tartrate-resistant acid phosphatase 5b levels predicts differential lumbar spine bone mineral density response and fracture risk during romosozumab treatment.

Methods: This retrospective study analyzed 287 female patients (mean age, 76.9 years) treated with 210 mg monthly romosozumab for 12 months at a single center in Japan (2019–2025). Patients were classified into four groups by baseline procollagen type I N-terminal propeptide and tartrate-resistant acid phosphatase 5b levels above or below the women-only cohort median (59.5 ng/mL and 456 mU/dL, respectively): both high (n = 114), high/low (n = 30), low/high (n = 31), and both low (n = 112). A pre-specified sensitivity analysis used fixed cutoffs from published Japanese premenopausal reference data (65 ng/mL; 440 mU/dL).

Results: Lumbar spine bone mineral density change differed significantly across groups (Kruskal–Wallis p < 0.001). The both-high group showed the highest median gain (+11.0%), with 55.0% achieving > 10% increase, while the both-low group showed the lowest (+6.0%, 19.1% achieving > 10%; pairwise p < 0.001). The fracture rate was 2.6% versus 11.7% (Fisher’s exact test, p = 0.009). Multivariate logistic regression confirmed both-high status as an independent predictor of >10% response (odds ratio 3.35, 95% confidence interval 1.71–6.55, p < 0.001) and prior treatment as a negative predictor (odds ratio 0.38, p = 0.003). The sensitivity analysis with fixed cutoffs yielded qualitatively identical results (both-high odds ratio 2.84, 95% confidence interval 1.47–5.48, p = 0.002).

Conclusions: Combined baseline procollagen type I N-terminal propeptide and tartrate-resistant acid phosphatase 5b classification identified postmenopausal women with differential bone mineral density responses to romosozumab. The concordance between empirical cohort medians and published Japanese premenopausal upper reference limits suggests the classification can be operationalized with fixed, externally derived cutoffs in future studies.

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联合基线P1NP和TRAcP5b分类预测对romosozumab的不同骨密度反应：一项287名绝经后妇女的回顾性队列研究。

个体骨转换标志物预测对罗莫索单抗的骨密度反应；然而，他们的综合评估尚未得到评估。我们研究了基于基线前胶原I型n端前肽和酒石酸盐抗性酸性磷酸酶5b水平的简单分类是否预测罗莫索单抗治疗期间腰椎骨密度反应和骨折风险的差异。方法：本回顾性研究分析了287名女性患者（平均年龄76.9岁），在日本单一中心（2019-2025）接受每月210 mg romosozumab治疗12个月。根据基线前胶原I型n端前肽和酒石酸盐抗性酸性磷酸酶5b水平高于或低于女性队列中位数（分别为59.5 ng/mL和456 mU/dL）将患者分为四组：高（n = 114）、高/低（n = 30）、低/高（n = 31）和低（n = 112）。预先指定的敏感性分析使用日本发表的绝经前参考数据（65 ng/mL; 440 mU/dL）的固定截止值。结果：各组腰椎骨密度变化差异有统计学意义（Kruskal-Wallis p < 0.001）。双高组中位增益最高（+11.0%），55.0%达到> - 10%；双低组中位增益最低（+6.0%，19.1%达到> - 10%；两两p < 0.001）。骨折率分别为2.6%和11.7% （Fisher精确检验，p = 0.009）。多因素logistic回归证实，高状态是bbb10 %应答的独立预测因子（优势比3.35,95%置信区间1.71-6.55,p < 0.001），既往治疗是负预测因子（优势比0.38,p = 0.003）。采用固定截止点的敏感性分析得到了质量相同的结果（高比值比2.84,95%置信区间1.47-5.48,p = 0.002）。结论：综合基线前胶原I型n端前肽和抗酒石酸盐酸性磷酸酶5b分类可识别绝经后妇女对romosozumab的不同骨密度反应。实证队列中位数与日本公布的绝经前上限参考值之间的一致性表明，在未来的研究中，可以使用固定的、外部派生的截止值来进行分类。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Clinical Densitometry 医学-内分泌学与代谢

CiteScore

4.90

自引率

8.00%

发文量

审稿时长

90 days

期刊介绍： The Journal is committed to serving ISCD''s mission - the education of heterogenous physician specialties and technologists who are involved in the clinical assessment of skeletal health. The focus of JCD is bone mass measurement, including epidemiology of bone mass, how drugs and diseases alter bone mass, new techniques and quality assurance in bone mass imaging technologies, and bone mass health/economics. Combining high quality research and review articles with sound, practice-oriented advice, JCD meets the diverse diagnostic and management needs of radiologists, endocrinologists, nephrologists, rheumatologists, gynecologists, family physicians, internists, and technologists whose patients require diagnostic clinical densitometry for therapeutic management.