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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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© The Author [2006]. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

Risedronate, an effective treatment for glucocorticoid-induced bone loss in CKD patients with or without concomitant active vitamin D (PRIUS-CKD)

Naohiko Fujii, Takayuki Hamano, Satoshi Mikami, Yasuyuki Nagasawa, Yoshitaka Isaka, Toshiki Moriyama, Masaru Horio, Enyu Imai, Masatsugu Hori and Takahito Ito

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



  Abstract

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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