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

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Zoledronate

• Registration Number: NCT00213980
• Lead Sponsor: University of Wisconsin, Madison

Brief 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.

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.

Study Timeline

• Study Start: 2000-01
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Results First Submitted: 2017-08-02
• Status Verified: 2017-12
• Results First Submitted QC: 2017-12-06
• Results First Posted: 2018-01-05
• Last Update Submitted: 2019-11-14
• Last Update Posted: 2019-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zoledronate	Zoledronate	Zoledronate

Primary Outcome Measures

Name	Time	Method
Change in Bone Mineral Density (BMD) From Baseline to 1 Year	Up 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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States