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Completed

NCT Number: NCT00213980

Bone Mineral Density Effects of Zoledronate in 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Wisconsin

Madison, Wisconsin, 53792, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zoledronate

Drug

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

Other names: Zometa

Primary outcomes

  1. 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.

Secondary outcomes

  1. Rates of Metastases

    Time frame: Up to 1 year

    Determine whether zoledronate is associated in rates of bone, visceral, and all distant metastases.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start
2000
Primary completion
2008
Study completion
2008
First posted
Sep 21, 2005
Registry last updated
Nov 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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