Bone Mineral Density Effects of Zoledronate in Postmenopausal Women With Breast Cancer

This is a two arm, double-blind randomized study looking at the effect of zoledronate, a
bisphosphonate, on the bone mineral density (BMD) of postmenopausal women with breast cancer.
An approved bisphosphonate, alendronate, is of benefit in patients with osteoporosis,
however, this agent has a roughly 30% incidence of gastrointestinal symptoms and up to 50% of
patients may take the drug improperly, compromising absorption and potentially efficacy.
Zoledronate is a heterocyclic imidazole third generation bisphosphonate, which is
administered intravenously (IV) and has little toxicity. Zoledronate is more potent than
alendronate, and because of its route of administration it does not have the problems of poor
oral bioavailability and non-compliance.

Inclusion Criteria:

- Postmenopausal women, Stage III or axillary node positive

- Currently disease free of breast cancer and other invasive malignancies at the time of
registration

- No concurrent use of bisphosphonates

Exclusion Criteria:

- Metastatic disease