Chen Chung-Hwan, Chang Je-Ken, Lai Kuo-An, Hou Sheng-Mou, Chang Chih-Hao, Wang Gwo-Jaw
Kaohsiung Medical University and Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.
Arthritis Rheum. 2012 May;64(5):1572-8. doi: 10.1002/art.33498.
Osteonecrosis is one of the major debilitating skeletal disorders. Most patients with osteonecrosis of the femoral head eventually need surgery, usually total hip arthroplasty (THA), within a few years of onset. Previous studies showed that alendronate has a pharmacologic effect in reducing osteoclast activity and that it significantly reduced the incidence of collapse of the femoral head in the osteonecrotic hip. The purpose of this study was to determine the cumulative incidence of THA in patients with osteonecrosis of the femoral head and the time-to-event after treatment with alendronate versus placebo during the study period.
A 2-year multicenter, prospective, randomized, double-blind study was performed. From June 2005 to December 2006, 64 patients were enrolled and randomly assigned to the alendronate or placebo group. In patients with bilateral hip osteonecrosis who met the inclusion criteria, both hips were counted in the analyses. Five patients were excluded from the analysis because they did not comply with any of the study regimens. Seven patients were ineligible because they were not diagnosed as having stage IIC or stage IIIC disease according to the University of Pennsylvania system. Thus, a total of 52 patients (65 hips) were assessed in this study. Disease progression was evaluated by radiography and magnetic resonance imaging (MRI). The Harris Hip Score and the Short Form 36 health survey were used to rate hip function and quality of life, respectively.
There was no significant difference in radiographic and MRI data between the 2 study groups. Four of 32 hips in the alendronate treatment group underwent THA, while 5 of 33 hips in the placebo group had THA (P = 0.837). No differences were noted in disease progression, Harris Hip Scores, or Short Form 36 scores between the 2 groups.
Alendronate has no obvious effect on preventing the necessity for THA, reducing disease progression, or improving life quality.
骨坏死是主要的致残性骨骼疾病之一。大多数股骨头坏死患者最终在发病后几年内需要手术，通常是全髋关节置换术（THA）。先前的研究表明，阿仑膦酸盐具有降低破骨细胞活性的药理作用，并且它能显著降低坏死性髋关节中股骨头塌陷的发生率。本研究的目的是确定股骨头坏死患者行THA的累积发生率，以及在研究期间阿仑膦酸盐与安慰剂治疗后的事件发生时间。
进行了一项为期2年的多中心、前瞻性、随机、双盲研究。从2005年6月至2006年12月，招募了64例患者并随机分配至阿仑膦酸盐组或安慰剂组。符合纳入标准的双侧髋关节骨坏死患者，在分析中双侧髋关节均纳入统计。5例患者因未遵守任何研究方案而被排除在分析之外。7例患者不符合条件，因为根据宾夕法尼亚大学系统，他们未被诊断为II C期或II I C期疾病。因此，本研究共评估了52例患者（65个髋关节）。通过X线摄影和磁共振成像（MRI）评估疾病进展。分别使用Harris髋关节评分和简短健康调查问卷36项来评估髋关节功能和生活质量。
两个研究组之间的X线摄影和MRI数据无显著差异。阿仑膦酸盐治疗组的32个髋关节中有4个接受了THA，而安慰剂组的33个髋关节中有5个接受了THA（P = 0.837）。两组之间在疾病进展、Harris髋关节评分或简短健康调查问卷36项评分方面均未发现差异。
阿仑膦酸盐在预防THA的必要性、降低疾病进展或改善生活质量方面没有明显效果。
