title: Renal safety profiles of ibandronate 6 mg infused over 15 and 60 min: a randomized, open-label study.
abstract: BACKGROUND
  Clinical data show that a single, 15-min i.v. infusion of ibandronate 6 mg does not significantly alter renal function. We evaluated the effect on renal function of repeated 15-min infusions of ibandronate 6 mg in women with breast cancer and bone metastases.
  
  
  METHODS
  Patients were randomly assigned to i.v. ibandronate 6 mg every 3-4 weeks for < or =6 months, infusion over 15 min (n = 102) or 60 min (n = 28). The primary end point was the percentage of patients with increased serum creatinine of > or =44.2 micromol/l. Blood chemistry was assessed at each visit.
  
  
  RESULTS
  Two per cent [2/101; 95% confidence interval (CI) 0.2-7.0] of patients in the 15-min infusion arm and no patients (0/26; 95% CI 0.0-13.2) in the 60-min infusion arm had increased serum creatinine that met the primary end point. There were no clinically relevant changes in serum creatinine, creatinine clearance, or N-acetyl-beta-d-glucosaminidase, alpha(1)-microglobulin, or microalbuminuria. Most adverse events were mild or moderate. No clinically relevant changes were observed in vital signs, hematology, blood chemistry, or urine analysis.
  
  
  CONCLUSIONS
  Ibandronate 6 mg by 15-min infusion every 3-4 weeks appear to be consistent with those renal safety profiles of 60-min infusion.
authors.affiliation: Kantonsspital Graubünden, Chur, Switzerland. Electronic address: roger.vonmoos@onkologie.li.
authors.forename: R
authors.initials: R
authors.lastname: von Moos
authors.affiliation: Kantonsspital Baden, Baden, Switzerland.
authors.forename: C B
authors.initials: CB
authors.lastname: Caspar
authors.affiliation: Kantonsspital St Gallen, St Gallen, Switzerland.
authors.forename: B
authors.initials: B
authors.lastname: Thürlimann
authors.affiliation: Kantonsspital St Gallen, St Gallen, Switzerland.
authors.forename: R
authors.initials: R
authors.lastname: Angst
authors.affiliation: Kantonsspital Graubünden, Chur, Switzerland.
authors.forename: R
authors.initials: R
authors.lastname: Inauen
authors.affiliation: University Hospital, Salzburg, Austria.
authors.forename: R
authors.initials: R
authors.lastname: Greil
authors.affiliation: Hoffmann-La Roche Inc., Nutley, NJ, USA.
authors.forename: B
authors.initials: B
authors.lastname: Bergstrom
authors.affiliation: Roche Pharma (Schweiz) AG, Reinach, Switzerland.
authors.forename: K
authors.initials: K
authors.lastname: Schmieding
authors.affiliation: Wilhelminenspital, Vienna, Austria.
authors.forename: M
authors.initials: M
authors.lastname: Pecherstorfer
mesh_terms: D050071:Bone Density Conservation Agents / Q000008:administration & dosage*; D001859:Bone Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000556:secondary*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003404:Creatinine / Q000097:blood; D004164:Diphosphonates / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077557:Ibandronic Acid; D007262:Infusions, Intravenous; D007677:Kidney Function Tests; D009362:Neoplasm Metastasis / Q000188:drug therapy / Q000473:pathology; D011897:Random Allocation; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D003404:Creatinine; D000077557:Ibandronic Acid