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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

September 13, 2005
September 21, 2005
August 2, 2017
January 5, 2018
January 5, 2018
January 2000
April 2008   (Final data collection date for primary outcome measure)
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.
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
  • Rates of Metastases [ Time Frame: Up to 1 year ]
    Determine whether zoledronate is associated in rates of bone, visceral, and all distant metastases.
  • 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.
  • 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.
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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: Observation
    Observation only for 12 months
  • Active Comparator: Zoledronate
    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
68
Not Provided
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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00213980
CO 99103
Yes
Not Provided
Not Provided
University of Wisconsin, Madison
University of Wisconsin, Madison
Not Provided
Principal Investigator: Daniel Mulkerin, MD University of Wisconsin, Madison
University of Wisconsin, Madison
December 2017

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