Center for Diversity and Inclusion, Nagasaki University, 1-14 Bunkyo-machi, Nagasaki City, Nagasaki 852-8521, Japan.
Department of Nuclear Medicine, Kawasaki Medical School, 577 Matsushima, Kurashiki City, Okayama 701-0192, Japan.
Bone. 2018 Jan;106:179-186. doi: 10.1016/j.bone.2017.10.013. Epub 2017 Oct 12.
The effects of zoledronic acid on hip structural and biomechanical properties were evaluated in Japanese patients with osteoporosis by computed tomography (CT). The subjects included in this study were a subset of female subjects (zoledronic acid group, 49 subjects; placebo group, 53 subjects) in the phase 3 trial (ZONE study) who were available for multi-detector row CT (MDCT) scanning. Eligible subjects were those diagnosed with primary osteoporosis based on the Diagnostic Criteria for Primary Osteoporosis (2000) by the Japanese Society for Bone and Mineral Research and who had between one and four fractured vertebrae located between the fourth thoracic vertebra and the fourth lumbar vertebra. The subjects received a once-yearly intravenous infusion of zoledronic acid 5mg or placebo for two years. CT data were obtained at baseline and at 12 and 24months later and analyzed under blinded conditions. The results demonstrated that once-yearly intravenous infusion of zoledronic acid improved volumetric bone mineral density (vBMD), cortical bone geometry parameters, and CT-derived biomechanical parameters at the femoral neck, intertrochanteric region, and shaft; particularly at the intertrochanteric region, significant improvements in cortical bone geometry parameters and CT-derived biomechanical parameters, compared with those in the placebo group, were detectable early, at 12months. The present data suggest that zoledronic acid has a possibility to reduce the risk of hip fractures in Japanese patients with osteoporosis.
唑来膦酸对日本骨质疏松症患者髋部结构和生物力学特性的影响通过计算机断层扫描(CT)进行了评估。本研究的受试者是 3 期临床试验(ZONE 研究)中女性亚组的一部分(唑来膦酸组,49 例;安慰剂组,53 例),他们可进行多排 CT(MDCT)扫描。符合条件的受试者是根据日本骨与矿物质研究协会的原发性骨质疏松症诊断标准(2000 年)诊断为原发性骨质疏松症的患者,且他们的第 4 胸椎和第 4 腰椎之间有 1 到 4 个骨折椎体。受试者接受了为期两年的唑来膦酸 5mg 或安慰剂每年一次的静脉输注。在基线和 12 个月和 24 个月后获得 CT 数据,并在盲法条件下进行分析。结果表明,唑来膦酸每年一次的静脉输注可改善股骨颈、转子间区和骨干的体积骨密度(vBMD)、皮质骨几何参数和 CT 衍生的生物力学参数;特别是在转子间区,与安慰剂组相比,皮质骨几何参数和 CT 衍生的生物力学参数的显著改善可在 12 个月时早期检测到。这些数据表明唑来膦酸有可能降低日本骨质疏松症患者髋部骨折的风险。