NDT Advance Access originally published online on November 23, 2006
Nephrology Dialysis Transplantation 2007 22(6):1601-1607; doi:10.1093/ndt/gfl567
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Risedronate, an effective treatment for glucocorticoid-induced bone loss in CKD patients with or without concomitant active vitamin D (PRIUS-CKD)
Department of Internal Medicine, Osaka University School of Medicine, Suita, Japan
Correspondence and offprint requests to: Takahito Ito, MD, PhD, FASN Department of Internal Medicine, Osaka University School of Medicine, Box A8, 2-2 Yamada-oka, Suita, 565-0871, Japan. Email: i-taka{at}umin.ac.jp
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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
30 ml/min/1.73 m2) 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 2.5 mg/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 1 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.
Keywords: bisphosphonates; bone mineral density; glucocorticoids; osteoporosis; steroids; vitamin D
Received for publication: 20. 6.06
Accepted in revised form: 28. 8.06
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