Lewiecki E Michael, Keaveny Tony M, Kopperdahl David L, Genant Harry K, Engelke Klaus, Fuerst Thomas, Kivitz Alan, Davies Richard Y, Fitzpatrick Lorraine A
New Mexico Clinical Research & Osteoporosis Center, 300 Oak Street NE, Albuquerque, New Mexico 87106, USA.
J Clin Endocrinol Metab. 2009 Jan;94(1):171-80. doi: 10.1210/jc.2008-1807. Epub 2008 Oct 7.
Bone strength and fracture resistance are determined by bone mineral density (BMD) and structural, mechanical, and geometric properties of bone. DESIGN, SETTING, AND OBJECTIVES: This randomized, double-blind, placebo-controlled outpatient study evaluated effects of once-monthly oral ibandronate on hip and lumbar spine BMD and calculated strength using quantitative computed tomography (QCT) with finite element analysis (FEA) and dual-energy x-ray absorptiometry (DXA) with hip structural analysis (HSA).
Participants were women aged 55-80 yr with BMD T-scores -2.0 or less to -5.0 or greater (n = 93).
Oral ibandronate 150 mg/month (n = 47) or placebo (n = 46) was administered for 12 months.
The primary end point was total hip QCT BMD change from baseline; secondary end points included other QCT BMD sites, FEA, DXA, areal BMD, and HSA. All analyses were exploratory, with post hoc P values.
Ibandronate increased integral total hip QCT BMD and DXA areal BMD more than placebo at 12 months (treatment differences: 2.2%, P = 0.005; 2.0%, P = 0.003). FEA-derived hip strength to density ratio and femoral, peripheral, and trabecular strength increased with ibandronate vs. placebo (treatment differences: 4.1%, P < 0.001; 5.9%, P < 0.001; 2.5%, P = 0.011; 3.5%, P = 0.003, respectively). Ibandronate improved vertebral, peripheral, and trabecular strength and anteroposterior bending stiffness vs. placebo [7.1% (P < 0.001), 7.8% (P < 0.001), 5.6% (P = 0.023), and 6.3% (P < 0.001), respectively]. HSA-estimated femoral narrow neck cross-sectional area and moment of inertia and outer diameter increased with ibandronate vs. placebo (respectively 3.6%, P = 0.003; 4.0%, P = 0.052; 2.2%, P = 0.049).
Once-monthly oral Ibandronate for 12 months improved hip and spine BMD measured by QCT and DXA and strength estimated by FEA of QCT scans.
骨强度和抗骨折能力由骨矿物质密度（BMD）以及骨的结构、力学和几何特性决定。
设计、地点和目的：这项随机、双盲、安慰剂对照的门诊研究评估了每月口服一次伊班膦酸钠对髋部和腰椎骨密度的影响，并使用定量计算机断层扫描（QCT）结合有限元分析（FEA）以及双能X线吸收法（DXA）结合髋部结构分析（HSA）来计算骨强度。
参与者为年龄在55至80岁之间、骨密度T值为-2.0或更低至-5.0或更高的女性（n = 93）。
给予口服伊班膦酸钠150毫克/月（n = 47）或安慰剂（n = 46），持续12个月。
主要终点是全髋QCT骨密度相对于基线的变化；次要终点包括其他QCT骨密度部位、FEA、DXA、面积骨密度和HSA。所有分析均为探索性分析，采用事后P值。
在12个月时，伊班膦酸钠使全髋QCT积分骨密度和DXA面积骨密度的增加幅度超过安慰剂（治疗差异：2.2%，P = 0.005；2.0%，P = 0.003）。与安慰剂相比，伊班膦酸钠使FEA得出的髋部强度与密度比以及股骨、外周和小梁强度增加（治疗差异分别为：4.1%，P < 0.分；5.9%，P < 0.001；2.5%，P = 0.011；3.5%，P = 0.003）。与安慰剂相比，伊班膦酸钠改善了椎体、外周和小梁强度以及前后弯曲刚度[分别为7.1%（P < 0.001）、7.8%（P < 0.001）、5.6%（P = 0.023）和6.3%（P < 0.001）]。与安慰剂相比，HSA估计的股骨窄颈横截面积、惯性矩和外径随着伊班膦酸钠的使用而增加（分别为3.6%，P = 0.003；4.0%，P = 0.052；2.2%，P = 0.049）。
每月口服一次伊班膦酸钠，持续12个月，可改善通过QCT和DXA测量的髋部和脊柱骨密度以及通过QCT扫描的FEA估计的骨强度。
