Wilkinson J M, Stockley I, Peel N F, Hamer A J, Elson R A, Barrington N A, Eastell R
Division of Clinical Sciences, University of Sheffield, Northern General Hospital, United Kingdom.
J Bone Miner Res. 2001 Mar;16(3):556-64. doi: 10.1359/jbmr.2001.16.3.556.
Acute periprosthetic bone loss occurs after total hip arthroplasty. Bone loss undermines the support of the implant and may contribute to prosthetic failure. At present, there is no established prophylaxis for this process. We studied the effect of a single-dose infusion of 90 mg of pamidronate on early periprosthetic bone mineral density (BMD), biochemical markers of bone turnover, radiological, and clinical outcome in a 26-week, prospective, randomized, double-blinded study of 47 men and women undergoing total hip arthroplasty. Pamidronate therapy led to a significant reduction in bone loss compared with placebo for both the proximal femur and the pelvis (repeated measures analysis of variance [ANOVA]); p = 0.001 and p = 0.01, respectively). Pamidronate therapy was associated with suppression of all biochemical markers of bone turnover compared with placebo (repeated measures ANOVA; p < 0.05 for all comparisons), with the exception of urinary free deoxypyridinoline. Pamidronate did not interfere with the clinical improvement in symptoms after total hip arthroplasty, or radiological outcome, and was not associated with an increase in adverse events. This study provides clinical data on the efficacy and safety of bisphosphonates for the prevention of bone loss after total hip arthroplasty and supports the establishment of larger-scale clinical trials to determine the long-term clinical efficacy of this intervention using implant failure as the primary endpoint.
全髋关节置换术后会发生急性假体周围骨丢失。骨丢失会削弱植入物的支撑,并可能导致假体失败。目前,对于这一过程尚无既定的预防措施。在一项为期26周的前瞻性、随机、双盲研究中,我们对47名接受全髋关节置换术的男性和女性进行了研究,探讨单次输注90毫克帕米膦酸盐对早期假体周围骨矿物质密度(BMD)、骨转换生化标志物、放射学及临床结局的影响。与安慰剂相比,帕米膦酸盐治疗使股骨近端和骨盆的骨丢失均显著减少(重复测量方差分析[ANOVA]);分别为p = 0.001和p = 0.01)。与安慰剂相比,帕米膦酸盐治疗与所有骨转换生化标志物的抑制相关(重复测量方差分析;所有比较p < 0.05),尿游离脱氧吡啶啉除外。帕米膦酸盐不干扰全髋关节置换术后症状的临床改善或放射学结局,且与不良事件增加无关。本研究提供了关于双膦酸盐预防全髋关节置换术后骨丢失的疗效和安全性的临床数据,并支持开展更大规模的临床试验,以确定以植入物失败为主要终点的该干预措施的长期临床疗效。