Bone Mineral Density Effects of Zoledronate in Postmenopausal Women With Breast Cancer
18 Years
N/A
Female
Breast Cancer
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:
Interventional
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:
No
Principal Investigator
Daniel Mulkerin, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Wisconsin, Madison
Authority:
United States: Institutional Review Board
Study ID:
CO 99103
NCT ID:
NCT00213980
Start Date:
January 2000
Completion Date:
April 2008
Related Keywords:
- Breast Cancer
- bone mineral density
- postmenopausal women
- Breast Neoplasms
Name | Location |
|---|---|
| University of Wisconsin | Madison,, Wisconsin 53792-5666 |
