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

November 14, 2019 updated by: University of Wisconsin, Madison
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Observation
Observation only for 12 months
Active Comparator: Zoledronate
Drug: Zoledronate
4 mg IV over 15 minutes administered once every 12 weeks times 4
Other Names:
  • Zometa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Bone Mineral Density (BMD) From Baseline to 1 Year
Time Frame: 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.
Up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of Metastases
Time Frame: Up to 1 year
Determine whether zoledronate is associated in rates of bone, visceral, and all distant metastases.
Up to 1 year
Overall Survival
Time Frame: Up to 10 years
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
Time Frame: Up to 1 year
Tolerability and side effects of ZA, measured by the number of participants experiencing adverse events.
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Daniel Mulkerin, MD, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Actual)

November 27, 2019

Last Update Submitted That Met QC Criteria

November 14, 2019

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CO99103
  • A534260 (Other Identifier: UW Madison)
  • SMPH/MEDICINE/MEDICINE*H (Other Identifier: UW Madison)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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