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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00213980
First Posted: September 21, 2005
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Bone Mineral Density Effects of Zoledronate in Postmenopausal Women With Breast Cancer

Resource links provided by NLM:


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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00213980     History of Changes
Other Study ID Numbers: CO 99103
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: October 12, 2017
Last Verified: January 2013

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