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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Zoledronate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Observation<br>Observation only for 12 months | |
| Active Comparator: Zoledronate<br>Zoledronate | Drug: Zoledronate<br>* 4 mg IV over 15 minutes administered once every 12 weeks times 4<br>* Other names: Zometa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of Metastases | Determine whether zoledronate is associated in rates of bone, visceral, and all distant metastases. | Up to 1 year | 
| Overall Survival | Number of participants who survived from the start of treatment through off treatment, up to 10 years. | Up to 10 years | 
| Clinical Toxicity of ZA | Tolerability and side effects of ZA, measured by the number of participants experiencing adverse events. | Up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bone mineral density, postmenopausal women