Renal safety profiles of ibandronate 6 mg infused over 15 and 60 min: a randomized, open-label study.
von Moos, R. 1,*; Caspar, C. B. 2; Thurlimann, B. 3; Angst, R. 3; Inauen, R. 1; Greil, R. 4; Bergstrom, B. 5; Schmieding, K. 6; Pecherstorfer, M. 7
[Article] Annals of Oncology. 19(7):1266-1270, July 2008.

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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 [mu]mol/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.

(C) 2008 The European Society for Medical Oncology