Renal safety profiles of ibandronate 6 mg infused over 15 and 60 min: a randomized, open-label study

R von Moos, C B Caspar, B Thürlimann, R Angst, R Inauen, R Greil, B Bergstrom, K Schmieding, M Pecherstorfer

Research output: Journal article (peer-reviewed)Journal article

17 Citations (Scopus)


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. Patients and methods: Patients were randomly assigned to i.v. ibandronate 6 mg every 3-4 weeks for ≤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 ≥44.2 μmol/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-β-d-glucosaminidase, α 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.

Original languageEnglish
Pages (from-to)1266-1270
Number of pages5
JournalAnnals of Oncology
Issue number7
Publication statusPublished - Jul 2008
Externally publishedYes


  • Bone Density Conservation Agents/administration & dosage
  • Bone Neoplasms/drug therapy
  • Breast Neoplasms/drug therapy
  • Creatinine/blood
  • Diphosphonates/administration & dosage
  • Drug Administration Schedule
  • Female
  • Follow-Up Studies
  • Humans
  • Ibandronic Acid
  • Infusions, Intravenous
  • Kidney Function Tests
  • Neoplasm Metastasis/drug therapy
  • Random Allocation
  • Time Factors
  • Treatment Outcome
  • Randomized clinical trial
  • Renal function
  • Breast cancer
  • Bisphosphonates
  • Bone metastases
  • Ibandronate

ASJC Scopus subject areas

  • Hematology
  • Oncology


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