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

Information source: University of Wisconsin, Madison
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer

Intervention: Zoledronate (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: University of Wisconsin, Madison

Official(s) and/or principal investigator(s):
Daniel Mulkerin, MD, Principal Investigator, Affiliation: University of Wisconsin, Madison

Summary

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.

Clinical Details

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

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

Primary outcome: 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

Secondary outcome: To determine whether zoledronate 4 mg IV every 12 weeks x 4 doses is associated with decreases in rates of bone metastasis, visceral metastasis, and overall mortality

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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

Locations and Contacts

University of Wisconsin, Madison, Wisconsin 53792, United States
Additional Information

Starting date: January 2000
Last updated: January 16, 2013

Page last updated: August 23, 2015

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