Abstract
534 Background: There is a correlation between suppression of bone resorption markers and the rate of reduction in skeletal-related events (SREs). Data for oral clodronate suggest that orally administered bisphosphonates may not be as effective as i.v. bisphosphonates. However, there have been no head-to-head randomized clinical trials. This multicenter, randomized, open-label, parallel group study directly compares oral ibandronate with i.v. zoledronic acid with respect to biochemical markers of bone turnover. Methods: Advanced breast cancer patients with at least one confirmed osteolytic or mixed bone lesion received oral ibandronate 50mg/day (n=114) or i.v. zoledronic acid 4mg (n=110), infused over 15 minutes every 4 weeks for 12 weeks. Eligibility criteria included: ≥18 years of age; life expectancy ≥6 months, WHO Performance Status of 0, 1 or 2; adequate renal function (serum creatinine ≤3.0 mg/dL). The primary endpoint was the mean percentage change in cross-linked C-terminal telopeptide of type I c...
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