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
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Zoledronate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Bone Mineral Density Effects of Zoledronate in Postmenopausal Women With Breast Cancer|
|Study Start Date :||January 2000|
|Primary Completion Date :||April 2008|
|Study Completion Date :||April 2008|
No Intervention: Observation
Observation only for 12 months
Active Comparator: Zoledronate
4 mg IV over 15 minutes administered once every 12 weeks times 4
Other Name: Zometa
- 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.
- 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 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
|United States, Wisconsin|
|University of Wisconsin|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Daniel Mulkerin, MD||University of Wisconsin, Madison|