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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-31

Study Completion Date

2008-04-30

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.

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Observation

Observation only for 12 months

Group Type NO_INTERVENTION

No interventions assigned to this group

Zoledronate

Group Type ACTIVE_COMPARATOR

Zoledronate

Intervention Type DRUG

4 mg IV over 15 minutes administered once every 12 weeks times 4

Interventions

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Zoledronate

4 mg IV over 15 minutes administered once every 12 weeks times 4

Intervention Type DRUG

Other Intervention Names

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Zometa

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