Department of Musculoskeletal Regenerative Medicine, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.
Department of Orthopaedic Surgery, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita, Osaka 565-0871, Japan.
Bone. 2020 Nov;140:115574. doi: 10.1016/j.bone.2020.115574. Epub 2020 Aug 8.
To investigate the effects of prior treatment and the predictors of early treatment response to romosozumab (ROMO) in patients with postmenopausal osteoporosis.
In this prospective, observational, multicenter study, 130 treatment-naïve patients (Naïve; n = 37) or patients previously treated with bisphosphonates (BP; n = 33), denosumab (DMAb; n = 45), or teriparatide (TPTD; n = 15) (age, 75.0 years; T-scores of the lumbar spine [LS] -3.2 and femoral neck [FN] -2.9) were switched to ROMO based on their physician's decision. Bone mineral density (BMD) and serum bone turnover markers were evaluated for six months.
At six months, LS BMD changes were 13.6%, 7.5%, 3.6%, and 8.7% (P < .001 between groups) and FN BMD changes were 4.2%, 0.4%, 1.6%, and 1.5% (P = .16 between groups) for Naïve, BP, DMAb, and TPTD groups, respectively. Changes in N-terminal type I procollagen propeptide (PINP; μg/L) levels from baseline → one month were 72.7 → 139.0, 33.5 → 85.4, 30.4 → 54.3, and 98.4 → 107.4, and those of isoform 5b of tartrate-resistant acid phosphatase (TRACP-5b) (mU/dL) were 474.7 → 270.2, 277.3 → 203.7, 220.3 → 242.0, and 454.1 → 313.0 for Naïve, BP, DMAb, and TPTD groups, respectively. Multivariate regression analysis revealed that significant predictors of LS BMD change at six months were prior treatment difference (r = -3.1, P = .0027) and TRACP-5b percentage change (r = -2.8, P = .0071) and PINP value at one month (r = 3.2, P = .0021).
Early effects of ROMO on the increase in LS BMD are significantly affected by the difference of prior treatment and are predicted by the early change in bone turnover markers.
Early effects of ROMO on the increase in LS BMD at six months is significantly affected by the difference of prior treatment and also predicted by the early change of bone turnover markers in patients with postmenopausal osteoporosis.
探究绝经后骨质疏松症患者接受罗莫佐单抗（ROMO）治疗前的治疗情况及其对早期治疗反应的预测因素。
本前瞻性、观察性、多中心研究纳入了 130 例未经治疗的患者（初治组，n=37）或先前接受过双膦酸盐（BP）治疗（n=33）、地舒单抗（DMAb）治疗（n=45）或特立帕肽（TPTD）治疗（n=15）的患者（年龄 75.0 岁；腰椎（LS）骨密度 T 评分-3.2，股骨颈（FN）骨密度 T 评分-2.9）。根据医生的决定，这些患者转为 ROMO 治疗。治疗 6 个月时评估骨矿物质密度（BMD）和血清骨转换标志物。
6 个月时，初治组、BP 组、DMAb 组和 TPTD 组的 LS BMD 变化分别为 13.6%、7.5%、3.6%和 8.7%（组间差异 P<.001），FN BMD 变化分别为 4.2%、0.4%、1.6%和 1.5%（组间差异 P=0.16）。从基线至 1 个月时，N-端Ⅰ型原胶原氨基端前肽（PINP）水平的变化分别为 72.7→139.0、33.5→85.4、30.4→54.3 和 98.4→107.4，抗酒石酸酸性磷酸酶 5b（TRACP-5b）同工酶的变化分别为 474.7→270.2、277.3→203.7、220.3→242.0 和 454.1→313.0。多变量回归分析显示，LS BMD 变化 6 个月时的显著预测因子为先前治疗的差异（r=-3.1，P=0.0027）和 TRACP-5b 百分比变化（r=-2.8，P=0.0071）以及 1 个月时的 PINP 值（r=3.2，P=0.0021）。
ROMO 对 LS BMD 增加的早期作用显著受先前治疗差异的影响，并可通过骨转换标志物的早期变化来预测。
