Ibandronate

In a phase II trial, patients with breast cancer metastatic to bone (N = 466) received either IV ibandronate (6 mg via 1- to 2-hour infusion or 2 mg via bolus injection) or placebo every 3-4 weeks (25). The primary endpoint was the skeletal morbidity period rate (SMPR; the number of 12-week periods with a skeletal complication divided by time on study). Ibandronate 6 mg significantly reduced the mean SMPR (1.19 versus 1.48 for placebo; P = 0.004) and significantly prolonged the median time to a first new bone event (50.6 weeks versus 33.1 weeks for placebo; P = 0.018) (25). However, ibandronate 6 mg did not significantly reduce the proportion of patients with a skeletal complication (50.6% versus 62.0% for placebo; P = 0.052) (25). In 2 pooled phase III trials, patients with bone metastases from breast cancer were randomized to receive oral ibandronate 50 mg (N = 287) or placebo (N = 277) daily for 96 weeks (23). Ibandronate significantly reduced the mean SMPR (0.95 versus 1.18; P = 0.004) and risk of SREs (hazard ratio = 0.62; P = 0.0001) compared with placebo, but did not significantly reduce the proportion of patients with an SRE (45.3% versus 52.2% compared with placebo; P = 0.122) (23). Because ibandronate has not yet been compared with other bisphosphonates, the clinical benefit of ibandronate compared with either pamidronate or zoledronic acid is not known.

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