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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

September 13, 2005
January 16, 2013
January 2000
April 2008   (final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00213980 on ClinicalTrials.gov Archive Site
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 ]
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.
Not Provided
Not Provided
 
Bone Mineral Density Effects of Zoledronate in Postmenopausal Women With Breast Cancer
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Breast Cancer
Drug: Zoledronate
4 mg IV over 15 minutes administered once every 12 weeks times 4
Other Name: Zometa
  • No Intervention: A
    Observation only for 12 months
  • Active Comparator: B
    Zoledronate
    Intervention: Drug: Zoledronate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
April 2008
April 2008   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00213980
CO 99103
Yes
University of Wisconsin, Madison
University of Wisconsin, Madison
Not Provided
Principal Investigator: Daniel Mulkerin, MD University of Wisconsin, Madison
University of Wisconsin, Madison
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP