Bone Mineral Density Effects of Zoledronate in Postmenopausal Women With Breast Cancer
3 other identifiers
interventional
68
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 breast-cancer
Started Jan 2000
Longer than P75 for phase_2 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2000
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedResults Posted
Study results publicly available
January 5, 2018
CompletedNovember 27, 2019
December 1, 2017
8.3 years
September 13, 2005
August 2, 2017
November 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Bone Mineral Density (BMD) From Baseline 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.
Up to 1 year
Secondary Outcomes (3)
Rates of Metastases
Up to 1 year
Overall Survival
Up to 10 years
Clinical Toxicity of ZA
Up to 1 year
Study Arms (2)
Observation
NO INTERVENTIONObservation only for 12 months
Zoledronate
ACTIVE COMPARATORZoledronate
Interventions
4 mg IV over 15 minutes administered once every 12 weeks times 4
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Metastatic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Wisconsin
Madison, Wisconsin, 53792, United States
Related Publications (1)
Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.
PMID: 38979716DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Daniel Mulkerin
- Organization
- University of Wisconsin Carbone Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Mulkerin, MD
University of Wisconsin, Madison
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
January 1, 2000
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
November 27, 2019
Results First Posted
January 5, 2018
Record last verified: 2017-12