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Tolerability of Different Dosing Regimens of Bisphosphonates for the Treatment of Osteoporosis and Malignant Bone Disease

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Abstract

Bisphosphonates are the primary pharmacological agents used for the management of osteoporosis and hypercalcaemia of malignant bone disease. The efficacy of these agents in these two conditions has been demonstrated in many well designed trials published over the past 2 decades. The variety of bisphosphonates currently available to us provides a wide range of tolerability and dosing profiles thus necessitating a thorough comparison of the most recent oral and intravenous bisphosphonates to differentiate the clinical context in which they should be used. Despite the fact that bisphosphonates are generally well accepted, their tolerability is dependent on complications which encompass gastrointestinal (GI) and renal toxicity. Other adverse events include osteonecrosis of the jaw, arthralgias, flu-like symptoms and uveitis. Studies have shown that various dosing regimens are able to modulate these rates of toxicity. To maximise tolerability, the direction of future therapy will likely fall into a pattern of decreasing the frequency of administration of bisphosphonates, whether it is oral or intravenous formulations, thus improving patient adherence.

To review the literature on different dosing regimens of various bisphosphonates and their associated tolerability, we searched MEDLINE for articles from 1975 to 2006. Oral bisphosphonates, in particular alendronate and risedronate, have been systematically evaluated with regards to GI toxicity. Overall tolerability with these oral formulations has found GI toxicity to be the primary adverse event of interest. Both alendronate and risedronate have been found to have similar rates of GI toxicity when compared with placebo. Mounting evidence has developed validating the use of intravenous ibandronate and zoledronic acid for the purpose of treating hypercalcaemia secondary to malignancy. Unique to all other bisphosphonates, ibandronate also has an oral form which has a similar GI-toxicity profile to placebo. In addition, no significant differences in renal toxicity have been observed between those receiving intravenous ibandronate compared with placebo. Because of its potency and mode of administration, zoledronic acid has been widely accepted for the treatment of hypercalcaemia secondary to malignancy. However, a decrease in renal function, albeit rare, remains a significant complication of zoledronic acid; therefore, regular renal monitoring is recommended.

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Acknowledgements

No sources of funding were used to assist in the preparation of this manuscript. Drs Bobba, Beattie, Parkinson and Kumbhare have no conflicts of interest directly relevant to the content of this review. Dr Adachi has given presentations for or conducted clinical trials for the following companies: Allelix, Amgen, AstraZeneca, Eli Lilly, GlaxoSmithKline, Merck, Novartis, Pfizer, Procter & Gamble, Roche, Sanofi-Aventis, Servier and Wyeth.

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  1. Division of Rheumatology, McMaster University, Suite 501 - 25 Charlton Avenue East, Hamilton, L8N 1Y2, Ontario, Canada

    Raja S Bobba, Karen Beattie &  Jonathan D. Adachi

  2. School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada

    Bill Parkinson

  3. Department of Medicine, McMaster University, Hamilton, Ontario, Canada

    Dinesh Kumbhare

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Bobba, R.S., Beattie, K., Parkinson, B. et al. Tolerability of Different Dosing Regimens of Bisphosphonates for the Treatment of Osteoporosis and Malignant Bone Disease. Drug-Safety 29, 1133–1152 (2006). https://doi.org/10.2165/00002018-200629120-00005

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