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
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