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

Phase 2
18 Years
Not Enrolling
Breast Cancer

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Trial Information

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

To determine whether zoledronate 4 mg IV every 12 weeks x 4 doses is associated with increases in bone mineral density at the lumbar spine and femoral head

Outcome Time Frame:

3rd bone mineral density assessment

Safety Issue:


Principal Investigator

Daniel Mulkerin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison


United States: Institutional Review Board

Study ID:

CO 99103



Start Date:

January 2000

Completion Date:

April 2008

Related Keywords:

  • Breast Cancer
  • bone mineral density
  • postmenopausal women
  • Breast Neoplasms



University of Wisconsin Madison,, Wisconsin  53792-5666