Division of Endocrinology, Diabetes and Metabolism, University Hospital Basel, Missionsstrasse 24, CH-4055, Basel, Switzerland,
Osteoporos Int. 2014 Jan;25(1):359-66. doi: 10.1007/s00198-013-2581-5. Epub 2013 Nov 22.
Based on this double-blind, placebo-controlled study, ibandronate has no beneficial effect on clinical and radiological outcome in patients with spontaneous osteonecrosis of the knee over and above anti-inflammatory medication.
Observational studies suggest beneficial effects of bisphosphonates in spontaneous osteonecrosis (ON) of the knee. We investigated whether ibandronate would improve clinical and radiological outcome in newly diagnosed ON.
In this randomized, double-blind, placebo-controlled trial, 30 patients (mean age, 57.3 ± 10.7 years) with ON of the knee were assigned to receive either ibandronate (cumulative dose, 13.5 mg) or placebo intravenously (divided into five doses 12 weeks). All subjects received additional treatment with oral diclofenac (70 mg) and supplementation with calcium carbonate (500 mg) and vitamin D (400 IU) to be taken daily for 12 weeks. Patients were followed for 48 weeks. The primary outcome was the change in pain score after 12 weeks. Secondary endpoints included changes in pain score, mobility, and radiological outcome (MRI) after 48 weeks.
At baseline, both treatment groups (IBN, n = 14; placebo, n = 16) were comparable in relation to pain score and radiological grading (bone marrow edema, ON). After 12 weeks, mean pain score was reduced in both ibandronate- (mean change, -2.98; 95% CI, -4.34 to -1.62) and placebo- (-3.59; 95% CI, -5.07 to -2.12) treated subjects (between-group comparison adjusted for age, sex, and osteonecrosis type, p = ns). Except for significant decrease in bone resorption marker (CTX) in ibandronate-treated subjects (p < 0.01), adjusted mean changes in all functional and radiological outcome measures were comparable between treatment groups after 24 and 48 weeks.
In patients with spontaneous osteonecrosis of the knee, bisphosphonate treatment (i.e., IV ibandronate) has no beneficial effect over and above anti-inflammatory medication.
基于这项双盲、安慰剂对照研究，在自发性膝关节骨坏死患者中，除了抗炎药物外，伊班膦酸盐对临床和影像学结果没有有益影响。
观察性研究表明，双膦酸盐对膝关节自发性骨坏死（ON）有有益作用。我们研究了伊班膦酸盐是否会改善新诊断的 ON 的临床和影像学结果。
在这项随机、双盲、安慰剂对照试验中，30 名（平均年龄 57.3±10.7 岁）膝关节 ON 患者被分配接受静脉内伊班膦酸盐（累积剂量 13.5mg）或安慰剂（n=15）。所有患者均接受额外的口服双氯芬酸（70mg）治疗，并补充碳酸钙（500mg）和维生素 D（400IU），每天一次，持续 12 周。患者随访 48 周。主要结局是治疗 12 周后疼痛评分的变化。次要终点包括治疗 48 周后疼痛评分、活动度和影像学结果（MRI）的变化。
在基线时，伊班膦酸盐组（n=14）和安慰剂组（n=16）在疼痛评分和影像学分级（骨髓水肿、ON）方面均具有可比性。治疗 12 周后，伊班膦酸盐组（平均变化-2.98；95%CI，-4.34 至-1.62）和安慰剂组（-3.59；95%CI，-5.07 至-2.12）的疼痛评分均降低（两组间比较调整年龄、性别和骨坏死类型，p=ns）。除伊班膦酸盐治疗组骨吸收标志物（CTX）显著下降外（p<0.01），治疗 24 周和 48 周后，两组间所有功能和影像学结果指标的调整后的平均变化均相似。
在自发性膝关节骨坏死患者中，与抗炎药物相比，双膦酸盐治疗（即静脉内伊班膦酸盐）没有有益作用。
