Shapiro J, Smith B, Beck T, Ballard P, Dapthary M, BrintzenhofeSzoc K, Caminis J
Department of Physical Medicine and Rehabilitation, Kennedy Krieger Institute, 707 North Broadway, Baltimore, MD 21205, USA.
Calcif Tissue Int. 2007 May;80(5):316-22. doi: 10.1007/s00223-007-9012-6. Epub 2007 Apr 7.
Acute spinal cord injury is associated with rapid bone loss and an increased risk of fracture. In this double-blind, randomized, placebo-controlled trial, 17 patients were followed for 1 year after administration of either 4 or 5 mg of zoledronic acid or placebo. Bone mineral density (BMD) and structural analyses of the proximal femur were performed using the hip structural analysis program at entry, 6 months, and 12 months. The 17 subjects completed 12 months of observation, nine receiving placebo and eight zoledronic acid. The placebo group showed a decrease in BMD, cross-sectional area, and section modulus and an increase in buckling ratio at each proximal femur site at 6 and 12 months. Six months after zoledronic acid, BMD, cross-sectional area, and section modulus increased at the femoral neck and intertrochanteric regions and buckling ratio decreased consistent with improved bone stability. However, at 12 months, the femoral narrow-neck values declined to baseline. In contrast to placebo, the intertrochanteric region and femur shaft were maintained at or near baseline through 12 months in the zoledronic acid-treated group. Urine N-telopeptide excretion was increased at baseline and declined in both the placebo and treatment groups during the 12 months of observation. We conclude that a single administration of zoledronic acid will ameliorate bone loss and maintain parameters of bone strength at the three proximal femur sites for 6 months and at the femur intertrochanteric and shaft sites for 12 months.
急性脊髓损伤与快速骨质流失及骨折风险增加相关。在这项双盲、随机、安慰剂对照试验中,17名患者在给予4或5毫克唑来膦酸或安慰剂后随访1年。在入组时、6个月和12个月时,使用髋部结构分析程序对股骨近端进行骨密度(BMD)和结构分析。17名受试者完成了12个月的观察,9人接受安慰剂,8人接受唑来膦酸。安慰剂组在6个月和12个月时,每个股骨近端部位的骨密度、横截面积和截面模量均下降,屈曲比增加。唑来膦酸治疗6个月后,股骨颈和转子间区域的骨密度、横截面积和截面模量增加,屈曲比降低,这与骨稳定性改善一致。然而,在12个月时,股骨窄颈值降至基线水平。与安慰剂组不同,唑来膦酸治疗组的转子间区域和股骨干在12个月内维持在基线水平或接近基线水平。尿N-端肽排泄在基线时增加,在观察的12个月期间,安慰剂组和治疗组均下降。我们得出结论,单次给予唑来膦酸将改善骨质流失,并在6个月内维持股骨近端三个部位以及在12个月内维持股骨转子间和骨干部位的骨强度参数。