Annals of Oncology Advance Access originally published online on March 11, 2008
Annals of Oncology 2008 19(7):1266-1270; doi:10.1093/annonc/mdn038
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breast cancer |
Renal safety profiles of ibandronate 6 mg infused over 15 and 60 min: a randomized, open-label study
1 Kantonsspital Graubünden, Chur, Switzerland
2 Kantonsspital Baden, Baden, Switzerland
3 Kantonsspital St Gallen, St Gallen, Switzerland
4 University Hospital, Salzburg, Austria
5 Hoffmann-La Roche Inc., Nutley, NJ, USA
6 Roche Pharma (Schweiz) AG, Reinach, Switzerland
7 Wilhelminenspital, Vienna, Austria
* Correspondence to: Dr R. von Moos, Medizinische Onkologie, Kantonsspital Graubünden, Loëstrasse 170, 7000 Chur, Switzerland. Tel: +41-812-566-646; Fax: +41812566640; E-mail: roger.vonmoos{at}onkologie.li
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, 
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.
Key words: bisphosphonates, bone metastases, breast cancer, ibandronate, randomized clinical trial, renal function
Received for publication November 13, 2007. Revision received January 22, 2008. Accepted for publication January 24, 2008.