Kashii Masafumi, Kamatani Takashi, Nagayama Yoshio, Miyama Akira, Tsuboi Hideki, Ebina Kosuke
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.
Osteoporos Int. 2023 Mar;34(3):563-572. doi: 10.1007/s00198-022-06642-1. Epub 2022 Dec 31.
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.
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.
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.
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).
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.
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。
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。
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。
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)。
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。