title: Risedronate, an effective treatment for glucocorticoid-induced bone loss in CKD patients with or without concomitant active vitamin D (PRIUS-CKD).
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 enrolling 114 CKD patients (creatinine clearance > or =30 ml/min/1.73 m(2)) receiving glucocorticoid therapy for > or =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.
authors.affiliation: FASN Department of Internal Medicine, Osaka University School of Medicine, Box A8, 2-2 Yamada-oka, Suita 565-0871, Japan.
authors.forename: Naohiko
authors.initials: N
authors.lastname: Fujii
authors.forename: Takayuki
authors.initials: T
authors.lastname: Hamano
authors.forename: Satoshi
authors.initials: S
authors.lastname: Mikami
authors.forename: Yasuyuki
authors.initials: Y
authors.lastname: Nagasawa
authors.forename: Yoshitaka
authors.initials: Y
authors.lastname: Isaka
authors.forename: Toshiki
authors.initials: T
authors.lastname: Moriyama
authors.forename: Masaru
authors.initials: M
authors.lastname: Horio
authors.forename: Enyu
authors.initials: E
authors.lastname: Imai
authors.forename: Masatsugu
authors.initials: M
authors.lastname: Hori
authors.forename: Takahito
authors.initials: T
authors.lastname: Ito
mesh_terms: D000328:Adult; D050071:Bone Density Conservation Agents / Q000494:pharmacology*; D001862:Bone Resorption / Q000139:chemically induced / Q000188:drug therapy* / Q000473:pathology; D002908:Chronic Disease; D004359:Drug Therapy, Combination; D012968:Etidronic Acid / Q000031:analogs & derivatives* / Q000494:pharmacology; D005260:Female; D006801:Humans; D007674:Kidney Diseases / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D011239:Prednisolone / Q000009:adverse effects* / Q000494:pharmacology; D011446:Prospective Studies; D000068296:Risedronic Acid; D014807:Vitamin D / Q000031:analogs & derivatives / Q000627:therapeutic use*
chemical_list: D050071:Bone Density Conservation Agents; D014807:Vitamin D; D011239:Prednisolone; D000068296:Risedronic Acid; D012968:Etidronic Acid