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唑来膦酸对比安慰剂对骨质疏松绝经后妇女脊柱骨密度和骨小梁骨评分评估的微结构的影响:一项为期三年的研究。

Effects of zoledronate versus placebo on spine bone mineral density and microarchitecture assessed by the trabecular bone score in postmenopausal women with osteoporosis: a three-year study.

机构信息

Department of Osteoporosis, Inselspital, Berne University Hospital and University of Berne, Berne, Switzerland.

出版信息

J Bone Miner Res. 2013 Mar;28(3):449-54. doi: 10.1002/jbmr.1775.

DOI:10.1002/jbmr.1775
PMID:23018784
Abstract

The trabecular bone score (TBS) is an index of bone microarchitectural texture calculated from anteroposterior dual-energy X-ray absorptiometry (DXA) scans of the lumbar spine (LS) that predicts fracture risk, independent of bone mineral density (BMD). The aim of this study was to compare the effects of yearly intravenous zoledronate (ZOL) versus placebo (PLB) on LS BMD and TBS in postmenopausal women with osteoporosis. Changes in TBS were assessed in the subset of 107 patients recruited at the Department of Osteoporosis of the University Hospital of Berne, Switzerland, who were included in the HORIZON trial. All subjects received adequate calcium and vitamin D3. In these patients randomly assigned to either ZOL (n = 54) or PLB (n = 53) for 3 years, BMD was measured by DXA and TBS assessed by TBS iNsight (v1.9) at baseline and 6, 12, 24, and 36 months after treatment initiation. Baseline characteristics (mean ± SD) were similar between groups in terms of age, 76.8 ± 5.0 years; body mass index (BMI), 24.5 ± 3.6 kg/m(2) ; TBS, 1.178 ± 0.1 but for LS T-score (ZOL-2.9 ± 1.5 versus PLB-2.1 ± 1.5). Changes in LS BMD were significantly greater with ZOL than with PLB at all time points (p < 0.0001 for all), reaching +9.58% versus +1.38% at month 36. Change in TBS was significantly greater with ZOL than with PLB as of month 24, reaching +1.41 versus-0.49% at month 36; p = 0.031, respectively. LS BMD and TBS were weakly correlated (r = 0.20) and there were no correlations between changes in BMD and TBS from baseline at any visit. In postmenopausal women with osteoporosis, once-yearly intravenous ZOL therapy significantly increased LS BMD relative to PLB over 3 years and TBS as of 2 years.

摘要

骨小梁评分(TBS)是一种基于腰椎(LS)前后位双能 X 射线吸收法(DXA)扫描的骨微观结构纹理指数,可预测骨折风险,与骨密度(BMD)无关。本研究旨在比较每年静脉注射唑来膦酸(ZOL)与安慰剂(PLB)对骨质疏松症绝经后妇女 LS BMD 和 TBS 的影响。在瑞士伯尔尼大学医院骨质疏松科招募的 107 例患者中评估了 TBS 的变化,这些患者被纳入 HORIZON 试验。所有患者均接受了足够的钙和维生素 D3。在这些患者中,随机分为 ZOL(n=54)或 PLB(n=53)组,治疗 3 年,在基线和治疗开始后 6、12、24 和 36 个月时通过 DXA 测量 BMD,并通过 TBS iNsight(v1.9)评估 TBS。两组间基线特征(均数±标准差)相似,年龄分别为 76.8±5.0 岁;体重指数(BMI)分别为 24.5±3.6kg/m2;TBS 分别为 1.178±0.1,但 LS T 评分分别为(ZOL-2.9±1.5 与 PLB-2.1±1.5)。在所有时间点,ZOL 组 LS BMD 的变化明显大于 PLB 组(所有 p<0.0001),在第 36 个月时分别达到+9.58%和+1.38%。从第 24 个月开始,ZOL 组的 TBS 变化明显大于 PLB 组,第 36 个月时分别达到+1.41%和-0.49%;p=0.031。LS BMD 和 TBS 呈弱相关(r=0.20),在任何一次就诊时,从基线开始,BMD 和 TBS 的变化之间均无相关性。在骨质疏松症绝经后妇女中,与 PLB 相比,每年一次静脉注射唑来膦酸治疗可显著增加 LS BMD,在第 2 年时也可增加 TBS。

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