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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00213980
First received: September 13, 2005
Last updated: January 16, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Drug: Zoledronate
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Bone Mineral Density Effects of Zoledronate in Postmenopausal Women With Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 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 [ Time Frame: 3rd bone mineral density assessment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine whether zoledronate 4 mg IV every 12 weeks x 4 doses is associated with decreases in rates of bone metastasis, visceral metastasis, and overall mortality [ Time Frame: follow every 6 months for life ] [ Designated as safety issue: No ]

Enrollment: 74
Study Start Date: January 2000
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: A
Observation only for 12 months
Active Comparator: B
Zoledronate
 Drug: Zoledronate
4 mg IV over 15 minutes administered once every 12 weeks times 4
Other Name: Zometa

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00213980

Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Daniel Mulkerin, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00213980     History of Changes
Other Study ID Numbers: CO 99103
Study First Received: September 13, 2005
Last Updated: January 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
bone mineral density
postmenopausal women

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013