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在既往未接受治疗的骨质疏松症女性中,基线血清PINP水平与使用罗莫索单抗治疗后髋部骨密度的增加相关。

Baseline serum PINP level is associated with the increase in hip bone mineral density seen with Romosozumab treatment in previously untreated women with osteoporosis.

作者信息

Kashii Masafumi, Kamatani Takashi, Nagayama Yoshio, Miyama Akira, Tsuboi Hideki, Ebina Kosuke

机构信息

Department of Orthopedic Surgery, Toyonaka Municipal Hospital, 4-14-1 Shibaharacho, Toyonaka, Osaka, 560-8565, Japan.

Nagayama Rheumatology and Orthopaedic Clinic, 4-3-25 Hiokisounishimachi, Higashi-Ku, Sakai, 599-8114, Japan.

出版信息

Osteoporos Int. 2023 Mar;34(3):563-572. doi: 10.1007/s00198-022-06642-1. Epub 2022 Dec 31.

Abstract

UNLABELLED

Baseline serum PINP value was significantly and independently associated with the increased bone mineral density (≥ 3%) in both total hip and femoral necks by 12 months of romosozumab treatment in patients with treatment-naive postmenopausal osteoporosis.

PURPOSE

Some patients fail to obtain a sufficiently increased hip bone mineral density (BMD) by romosozumab (ROMO) treatment. This study aimed to investigate the prognostic factor for increased hip BMD with ROMO in patients with treatment-naive postmenopausal osteoporosis.

METHODS

This prospective, observational, and multicenter study included patients (n = 63: mean age, 72.6 years; T-scores of the lumbar spine [LS], - 3.3; total hip [TH], - 2.6; femoral neck [FN], - 3.3; serum type I procollagen N-terminal propeptide [PINP], 68.5 µg/L) treated by ROMO for 12 months. BMD and serum bone turnover markers were evaluated at each time point. A responder analysis was performed to assess the patient percentage, and both univariate and multivariate analyses were performed to investigate the factors associated with clinically significant increased BMD (≥ 3%) in both TH and FN.

RESULTS

Percentage changes of BMD from baseline in the LS, TH, and FN areas were 17.5%, 4.9%, and 4.3%, respectively. In LS, 96.8% of patients achieved ≥ 6% increased LS-BMD, although 57.1% could not achieve ≥ 3% increased BMD in either TH or FN. Multiple regression analysis revealed that only the baseline PINP value was significantly and independently associated with ≥ 3% increased BMD in both TH and FN (p = 0.019, 95% confidence interval = 1.006-1.054). The optimal cut-off PINP value was 53.7 µg/L with 54.3% sensitivity and 92.3% specificity (area under the curve = 0.752).

CONCLUSIONS

In a real-world setting, baseline PINP value was associated with the increased BMD of TH and FN by ROMO treatment in treatment-naive patients.

摘要

未标注

在未经治疗的绝经后骨质疏松症患者中,通过12个月的罗莫佐单抗治疗,基线血清PINP值与全髋关节和股骨颈骨密度增加(≥3%)显著且独立相关。

目的

一些患者通过罗莫佐单抗(ROMO)治疗未能充分提高髋部骨密度(BMD)。本研究旨在调查未经治疗的绝经后骨质疏松症患者使用ROMO增加髋部BMD的预后因素。

方法

这项前瞻性、观察性、多中心研究纳入了接受ROMO治疗12个月的患者(n = 63;平均年龄72.6岁;腰椎[LS]T值为-3.3;全髋关节[TH]为-2.6;股骨颈[FN]为-3.3;血清I型前胶原N端前肽[PINP]为68.5μg/L)。在每个时间点评估BMD和血清骨转换标志物。进行应答者分析以评估患者百分比,并进行单变量和多变量分析以研究与TH和FN中临床上显著的BMD增加(≥3%)相关的因素。

结果

LS、TH和FN区域BMD相对于基线的百分比变化分别为17.5%、4.9%和4.3%。在LS中,96.8%的患者实现了LS-BMD增加≥6%,尽管57.1%的患者在TH或FN中均未实现BMD增加≥3%。多元回归分析显示,只有基线PINP值与TH和FN中BMD增加≥3%显著且独立相关(p = 0.019,95%置信区间 = 1.006 - 1.054)。最佳PINP截断值为53.7μg/L,敏感性为54.3%,特异性为92.3%(曲线下面积 = 0.752)。

结论

在实际临床环境中,基线PINP值与未经治疗的患者使用ROMO治疗后TH和FN的BMD增加相关。

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