Renal Safety Profiles of Ibandronate 6 Mg Infused Over 15 and 60 Min: A Randomized, Open-Label Study

Ann Oncol. 2008 Jul;19(7):1266-70. doi: 10.1093/annonc/mdn038. Epub 2008 Mar 11.

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.

Patients and 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.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Bone Density Conservation Agents / administration & dosage*
  • Bone Neoplasms / drug therapy*
  • Bone Neoplasms / pathology
  • Bone Neoplasms / secondary*
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / pathology
  • Creatinine / blood
  • Diphosphonates / administration & dosage*
  • Diphosphonates / adverse effects
  • Drug Administration Schedule
  • Female
  • Follow-Up Studies
  • Humans
  • Ibandronic Acid
  • Infusions, Intravenous
  • Kidney Function Tests
  • Neoplasm Metastasis / drug therapy
  • Neoplasm Metastasis / pathology
  • Random Allocation
  • Time Factors
  • Treatment Outcome

Substances

  • Bone Density Conservation Agents
  • Diphosphonates
  • Creatinine
  • Ibandronic Acid