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www.fdanews.com/articles/85620-study-ibandronate-and-iv-efficacious-in-treating-bone-metastases-of-breast-cancer

STUDY: IBANDRONATE AND IV EFFICACIOUS IN TREATING BONE METASTASES OF BREAST CANCER

March 28, 2006

Patients with metastatic bone disease due to breast cancer may respond equally well to oral ibandronate (Boniva) as they do to IV zoledronic acid (Zometa), according to research presented at the 5th European Breast Cancer Conference in Nice, France. The tolerability profile of oral ibandronate may provide another option for treating metastatic bone disease in breast cancer.

In the current research, a head-to-head, open-label, Phase III trial, investigators compared oral ibandronate and IV zoledronic acid regarding both their effects on bone turnover markers and their safety profiles. The study period was 12 weeks. The investigators recruited 254 patients with advanced breast cancer and confirmed bone lesions. Within this group, 128 received either oral ibandronate at a dose of 50 mg daily, and 126 received 4 mg of IV zoledronic acid every four weeks.

At the study's end, the investigators observed change in serum cross-linked C-terminal telopeptide of Type I collagen, a key marker of bone turnover. Other assessments included levels of urinary calcium, bone-specific alkaline phosphatase, amino-terminal procollagen propeptides of type I collagen, and osteocalcin. The investigators also recorded all adverse events.