Oral ibandronate for the treatment of metastatic bone disease in breast cancer: efficacy and safety results from a randomized, double-blind, placebo-controlled trial.
D Tripathy, M Lichinitzer, A Lazarev, SA MacLachlan, J Apffelstaedt, M Budde, B Bergstrom, undefined MF 4434 Study Group
Annals of Oncology | Published : 2004
BACKGROUND: We report the first results of a randomized trial assessing a new oral aminobisphosphonate, ibandronate, in patients with bone metastases from breast cancer. PATIENTS AND METHODS: Patients (n = 435) received placebo, or oral ibandronate 20 mg or 50 mg once-daily for 96 weeks. The primary efficacy measure was the number of 12-week periods with new bone complications [skeletal morbidity period rate (SMPR)]. Multivariate Poisson regression analysis assessed the relative risk reduction of skeletal-related events. Secondary efficacy analyses included bone pain and analgesic use. Adverse events were monitored. RESULTS: SMPR was significantly reduced with oral ibandronate [placebo 1.2, ..View full abstract