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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
68
4 mg IV over 15 minutes administered once every 12 weeks times 4
University of Wisconsin
Madison, Wisconsin, United States
Change in Bone Mineral Density (BMD) From Baseline to 1 Year
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, calculated from baseline and 1 year data. Participants who missed one or more DXA were not evaluated.
Time frame: Up to 1 year
Rates of Metastases
Determine whether zoledronate is associated in rates of bone, visceral, and all distant metastases.
Time frame: Up to 1 year
Overall Survival
Number of participants who survived from the start of treatment through off treatment, up to 10 years.
Time frame: Up to 10 years
Clinical Toxicity of ZA
Tolerability and side effects of ZA, measured by the number of participants experiencing adverse events.
Time frame: Up to 1 year
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