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

von Moos, R. and Caspar, C. B. and Thürlimann, B. and Angst, R. and Inauen, R. and Greil, R. and Bergstrom, B. and Schmieding, K. and Pecherstorfer, M.. (2008) Renal safety profiles of ibandronate 6 mg infused over 15 and 60 min : a randomized, open-label study. Annals of oncology, Vol. 19, H. 7. pp. 1266-1270.

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Official URL: http://edoc.unibas.ch/dok/A6006899

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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 > 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.
Faculties and Departments:03 Faculty of Medicine > Bereich Medizinische Fächer (Klinik) > Onkologie
03 Faculty of Medicine > Departement Klinische Forschung > Bereich Medizinische Fächer (Klinik) > Onkologie
UniBasel Contributors:Thürlimann, Beat
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:Oxford University Press
Note:Publication type according to Uni Basel Research Database: Journal article
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Last Modified:08 Nov 2012 16:23
Deposited On:08 Nov 2012 16:21

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