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

University of Wisconsin (UW)

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Drug: Zoledronate

Study type

Interventional

Funder types

Other

Identifiers

NCT00213980

CO99103

SMPH/MEDICINE/MEDICINE*H (Other Identifier)

A534260 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

68 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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