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Rapid administration of ibandronate does not affect renal functioning: evidence from clinical studies in metastatic bone disease and hypercalcaemia of malignancy

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Abstract

Ibandronate is a third-generation aminobisphosphonate that has an excellent safety record in hypercalcaemia of malignancy, and has recently been approved for the prevention of skeletal events from metastatic breast cancer. This paper reviews the safety data from clinical studies of intravenous ibandronate by infusion or injection, focusing on renal adverse events (AEs). In clinical trials of patients with hypercalcaemia of malignancy, 2-h infusions of ibandronate at doses of up to 6 mg had a low potential for renal events. In a phase III trial of patients with metastatic bone disease from breast cancer, 6 mg ibandronate infused over 1–2 h had a renal safety profile comparable to that of placebo. In pilot studies, repeated daily infusions of ibandronate (4 mg infused over 2 h for four consecutive days, or 6 mg infused over 1 h for three consecutive days) for severe metastatic bone pain were not associated with any renal AEs. The safety of single 15-min infusions of 6 mg ibandronate has been demonstrated in healthy volunteers and patients with metastatic bone disease from breast cancer or multiple myeloma. Furthermore, single and rapid bolus injections of 2 or 3 mg ibandronate did not increase the risk of renal dysfunction in patients with skeletal metastases. Implications for the renal safety of ibandronate in the management of patients with metastatic bone disease are discussed.

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Acknowledgements

Clinical trials of ibandronate in hypercalcaemia of malignancy and metastatic bone disease were conducted by Boehringer Mannheim. The authors were investigators in the studies. Data analysis was supported by F. Hoffmann-La Roche Ltd, Basel, Switzerland, who also provided the authors with access to unpublished data on file. Thomson Gardiner-Caldwell US provided editorial assistance.

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Authors and Affiliations

  1. First Department of Medicine and Oncology, Wilhelminenspital, Montleartstrasse 37, 1171, Vienna, Austria

    M. Pecherstorfer

  2. Centrum für ganzheitliche Gynäkologie (CGG)-Klinik GmbH, Quadrat P7, 16-18, 68161, Mannheim, Germany

    I. J. Diel

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  1. M. Pecherstorfer
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  2. I. J. Diel
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Correspondence to M. Pecherstorfer.

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Pecherstorfer, M., Diel, I.J. Rapid administration of ibandronate does not affect renal functioning: evidence from clinical studies in metastatic bone disease and hypercalcaemia of malignancy. Support Care Cancer 12, 877–881 (2004). https://doi.org/10.1007/s00520-004-0655-9

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  • DOI: https://doi.org/10.1007/s00520-004-0655-9

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