The effect of 3 versus 6 years of zoledronic acid treatment of osteoporosis: a randomized extension to the HORIZON-Pivotal Fracture Trial (PFT).
The effect of 3 versus 6 years of zoledronic acid treatment of osteoporosis: a randomized extension to the HORIZON-Pivotal Fracture Trial (PFT).
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DOI：
10.1002/jbmr.1494
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发表时间：
2012-02
影响因子：
6.2
通讯作者：
Eastell, Richard
中科院分区：
文献类型：
--
作者：
Black, Dennis M.;Reid, Ian R.;Boonen, Steven;Bucci-Rechtweg, Christina;Cauley, Jane A.;Cosman, Felicia;Cummings, Steven R.;Hue, Trisha F.;Lippuner, Kurt;Lakatos, Peter;Leung, Ping Chung;Man, Zulema;Martinez, Ruvie Lou Maria;Tan, Monique;Ruzycky, Mary Ellen;Su, Guoqin;Eastell, Richard
唑来膦酸每年5毫克(ZOL)，为期3年，可降低绝经后骨质疏松症妇女的骨折风险。为了研究ZOL对骨密度(BMD)和骨折风险的长期影响，将ZOL的健康结局和降低发生率的一年一次枢纽性骨折试验(Horizon-PFT)延长至6年。在这项多中心、双盲、安慰剂对照的国际扩展试验中，在核心研究中，1233名接受ZOL 3年的绝经后妇女被随机分为ZOL(Z6，n=616)或安慰剂(Z3P3，n=617)。主要终点是意向治疗(ITT)人群中股骨颈(FN)骨密度从第3年到第6年的百分比变化。次要终点包括其他骨密度部位、骨折、生化骨转换标记物和安全性。在第3至第6年，Z6的Fn-BMD保持不变，而Z3P3略有下降(治疗间差异=1.04%；95%可信区间0.4~1.7；p=0.0009)，但仍高于治疗前水平。其他骨密度部位也显示出类似的差异。Z6组生化指标保持不变，Z3P3组略有上升，均远低于治疗前水平。Z6组(n=14)和Z3P3组(n=30)新的椎体形态测量性骨折发生率较低(优势比=0.51；p=0.035)，而其他骨折无差异。更多的Z6患者的血清肌酐和Gt；0.5 mg/dL有一过性升高(0.65%比Z3P3的2.94%)。心房颤动严重不良事件(2.0%比Z3P3的1.1%；p=0.26)和卒中(3.1%比Z3P3的1.5%；p=0.06)的Z6无显著增加。两组服药后症状相似。Z6的高血压报告显著低于Z3P3(7.8%比15.1%，p<；0.001)。在继续治疗和停止治疗的患者中，骨密度和标记物的微小差异表明存在残留效应，因此，在每年服用ZOL 3年后，许多患者可能会停止治疗长达3年。然而，脊椎骨折的减少表明，那些有高骨折风险的人，特别是脊椎骨折，可能会从继续治疗中受益。(ClinicalTrials.gov标识：NCT00145327)。©2012美国骨与矿物研究学会。
Zoledronic acid 5 mg (ZOL) annually for 3 years reduces fracture risk in postmenopausal women with osteoporosis. To investigate long-term effects of ZOL on bone mineral density (BMD) and fracture risk, the Health Outcomes and Reduced Incidence with Zoledronic acid Once Yearly–Pivotal Fracture Trial (HORIZON-PFT) was extended to 6 years. In this international, multicenter, double-blind, placebo-controlled extension trial, 1233 postmenopausal women who received ZOL for 3 years in the core study were randomized to 3 additional years of ZOL (Z6, n = 616) or placebo (Z3P3, n = 617). The primary endpoint was femoral neck (FN) BMD percentage change from year 3 to 6 in the intent-to-treat (ITT) population. Secondary endpoints included other BMD sites, fractures, biochemical bone turnover markers, and safety. In years 3 to 6, FN-BMD remained constant in Z6 and dropped slightly in Z3P3 (between-treatment difference = 1.04%; 95% confidence interval 0.4 to 1.7; p = 0.0009) but remained above pretreatment levels. Other BMD sites showed similar differences. Biochemical markers remained constant in Z6 but rose slightly in Z3P3, remaining well below pretreatment levels in both. New morphometric vertebral fractures were lower in the Z6 (n = 14) versus Z3P3 (n = 30) group (odds ratio = 0.51; p = 0.035), whereas other fractures were not different. Significantly more Z6 patients had a transient increase in serum creatinine >0.5 mg/dL (0.65% versus 2.94% in Z3P3). Nonsignificant increases in Z6 of atrial fibrillation serious adverse events (2.0% versus 1.1% in Z3P3; p = 0.26) and stroke (3.1% versus 1.5% in Z3P3; p = 0.06) were seen. Postdose symptoms were similar in both groups. Reports of hypertension were significantly lower in Z6 versus Z3P3 (7.8% versus 15.1%, p < 0.001). Small differences in bone density and markers in those who continued versus those who stopped treatment suggest residual effects, and therefore, after 3 years of annual ZOL, many patients may discontinue therapy up to 3 years. However, vertebral fracture reductions suggest that those at high fracture risk, particularly vertebral fracture, may benefit by continued treatment. (ClinicalTrials.gov identifier: NCT00145327). © 2012 American Society for Bone and Mineral Research.
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