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

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ClinicalTrials.gov Identifier: NCT00213980
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : January 5, 2018
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Zoledronate Phase 2

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  (Clinical Trial)
Actual Enrollment : 68 participants
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
Study Start Date : January 2000
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Observation
Observation only for 12 months
Active Comparator: Zoledronate
Zoledronate
Drug: Zoledronate
4 mg IV over 15 minutes administered once every 12 weeks times 4
Other Name: Zometa



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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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

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

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00213980     History of Changes
Other Study ID Numbers: CO 99103
First Posted: September 21, 2005    Key Record Dates
Results First Posted: January 5, 2018
Last Update Posted: January 5, 2018
Last Verified: December 2017

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