A randomized, double-blind, placebo-controlled phase III trial of zoledronic acid in the prevention of skeletal complications in Japanese women with bone metastases from breast cancer

Bone Metastases in Breast Cancer

“…6 discussed above in similar populations of breast cancer patients with bone metastases demonstrates that zoledronic acid significantly reduced the percentage of patients with at least one SRE by 40% relative to placebo at one year (p=0.001). 10 IV pamidronate (90mg) significantly reduced, but to a lesser extent, the number of patients experiencing at least one SRE by approximately 22% relative to placebo at two years (p<0.001), 3 and both IV ibandronate (6mg) and oral ibandronate (50mg/day) failed to significantly reduce the percentage of patients with a new bone event relative to placebo at one year (18% and 13% relative reductions, respectively). 11,14…”

“…Both IV and oral bisphosphonates have been shown to provide significant clinical benefits in patients with bone metastases from breast cancer in randomized trials (see Table 1). 3,[9][10][11][12][13][14][15][16] Conservative assessments of treatment effects include first-event analyses, such as percentage of patients with at least one skeletal complication or time to first skeletal complication, and are preferred end-points for regulatory approval by the US Food and Drug Administration (FDA). 17 Treatment effect on incidence of pathologic fractures is particularly important.…”

“…Recently, a randomized, placebo-controlled study was conducted to investigate the efficacy of zoledronic acid in 228 Japanese women with bone metastases from breast cancer. 10 In this trial, patients were treated with zoledronic acid (4mg every four weeks) or placebo for one year. The primary end-point in this trial was the ratio of the SRE rate (defined as the total number of SREs divided by time on study) for patients treated with zoledronic acid versus placebo.…”