Oral ibandronate for the treatment of metastatic bone disease in breast cancer: efficacy and safety results from a randomized, double-blind, placebo-controlled trial

A. M. Westermann

Department of Medical Oncology, Academic Medical Center, Amsterdam, The Netherlands Email: a.m.westermann{at}amc.uva.nl

In their well-conducted randomized study on the efficacy of oral ibandronate to reduce the incidence of skeletal complications in breast cancer patients, Tripathy et al. [1Go] included a placebo group, even while acknowledging in their paper that bisphosphonates ‘are currently considered the standard of care for most patients’. It is unclear why it was considered ethical to withhold standard bisphosphonate treatment from 143 breast cancer patients.

The superiority of intravenous ibandronate over placebo has been well demonstrated in a recently published trial by the same group [2Go]. Although the concern I voiced about the ethics of including a placebo group in that study was published [3Go], no reaction from the authors was received. Perhaps the authors will now be inclined to clarify their position on this issue.


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1. Tripathy D, Lichinitzer M, Lazarev A et al. Oral ibandronate for the treatment of metastatic bone disease in breast cancer: efficacy and safety results from a randomized, double-blind, placebo-controlled trial. Ann Oncol 2004; 5: 743–750.[CrossRef]

2. Body J-J, Diel IJ, Lichinitser MR et al. Intravenous ibandronate reduces the incidence of skeletal complications with breast cancer and bone metastases in patients. Ann Oncol 2003; 14: 1399–1405.[Abstract/Free Full Text]

3. Westermann AM. Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases. Ann Oncol 2004; 15: 537–538.[Free Full Text]





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