Risedronate, an effective treatment for glucocorticoid-induced bone loss in CKD patients with or without concomitant active vitamin D (PRIUS-CKD)
Risedronate, an effective treatment for glucocorticoid-induced bone loss in CKD patients with or without concomitant active vitamin D (PRIUS-CKD)
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DOI：
10.1093/ndt/gfl567
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发表时间：
2007-06-01
影响因子：
6.1
通讯作者：
Ito, Takahito
中科院分区：
文献类型：
--
作者：
Fujii, Naohiko;Hamano, Takayuki;Ito, Takahito
背景最近的事后分析证明了利塞膦酸钠在伴有肾功能损害的肾病患者中的疗效和耐受性，但活性维生素D联合糖皮质激素治疗慢性肾病（CKD）患者的疗效尚不清楚。我们进行了一项前瞻性研究，纳入了114例接受糖皮质激素治疗≥ 6个月的CKD患者（肌酐清除率≥ 30 ml/min/1.73m2）。88名接受活性维生素D（aVD）治疗的受试者被随机分配到仅接受aVD治疗的组（A组）或同时接受利塞膦酸钠2.5 mg/天治疗的组（B组）。C组仅给予利塞膦酸钠治疗。1年后，对100名受试者进行了分析。利塞膦酸钠对腰椎有效，但对股骨颈无效。B组和C组腰椎骨密度（BMD）分别增加2.8和2.5%，而A组降低1.0%。B组和C组的血清I型胶原N端肽（S-NTX）和骨碱性磷酸酶（ALP）在3个月和6个月时分别显著下降，而A组的S-NTX保持不变，骨ALP显著升高。B组和C组的BMD和骨标志物无显著差异。6个月时S-NTX（骨ALP）降低率预测1年时腰椎BMD增加的敏感性为73%（34%），特异性为46.2%（100%）。利塞膦酸钠可有效增加接受长期糖皮质激素治疗的CKD患者的BMD（伴或不伴aVD）。骨标记物在预测抗吸收治疗的反应方面有一定的用处。
Background. Recent post hoc analysis proved the efficacy and tolerability of risedronate in osteoporotic patients with renal impairment, but the combination of active vitamin D in chronic kidney disease (CKD) patients taking glucocorticoids remains unknown.Methods. We conducted a prospective study enroling 114 CKD patients (creatinine clearance >= 30ml/min/1.73m(2)) receiving glucocorticoid therapy for >= 6 months. Eighty-eight subjects who had received active vitamin D (aVD) were randomly assigned to either a group treated with aVD only (group A), or to a group also receiving risedronate 2.5mg/day (group B). The remaining patients (group C) received risedronate only.Results. After 1 year 100 subjects were analysed. Risedronate was effective on the lumbar spine, but not on the femoral neck. The lumbar bone mineral density (BMD) significantly increased by 2.8 and 2.5% in groups B and C, respectively, but decreased by 1.0% in group A. Serum N-terminal telopeptides of type I collagen (S-NTX) and bone alkaline phosphatase (ALP) fell significantly in groups B and C at 3 and 6 months, respectively, while in group A S-NTX remained unchanged and bone ALP significantly increased. There was no significant difference between groups B and C regarding BMD and bone markers. The reduction rate of S-NTX (bone ALP) at 6 months predicted the increase in lumbar BMD at I year with a sensitivity of 73% (34%) and a specificity of 46.2% (100%).Conclusions. Risedronate is effective in increasing BMD with or without aVD in CKD patients receiving long-term glucocorticoid therapy. Bone markers are of some use in predicting the response to anti-resorptive therapy.