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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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Breast Cancer
Intervention: Drug: Zoledronate

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The University of Wisconsin Comprehensive Cancer Center (UWCCC) conducted a clinical trial of adjuvant ZA in postmenopausal women with high-risk breast cancer, open through the Wisconsin Oncology Network (WON). Participants were recruited from 2000 through 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Observation Observation only for 12 months
Zoledronic Acid (ZA)

ZA

Zoledronic acid (ZA): 4 mg IV over 15 minutes administered once every 12 weeks for 4 cycles


Participant Flow:   Overall Study
    Observation   Zoledronic Acid (ZA)
STARTED   32   36 
COMPLETED   26   29 
NOT COMPLETED   6   7 
Withdrawal by Subject                3                1 
Adverse Event                1                1 
Disease progression                0                2 
Developed ovarian cancer                1                0 
Failed to obtain all 3 DXAs                1                3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Postmenopausal women with stage II/III breast cancer diagnosed up to 5 years previous.

Reporting Groups
  Description
Observation Observation only for 12 months
Zoledronic Acid (ZA)

ZA

Zoledronic acid (ZA): 4 mg IV over 15 minutes administered once every 12 weeks for 4 cycles

Total Total of all reporting groups

Baseline Measures
   Observation   Zoledronic Acid (ZA)   Total 
Overall Participants Analyzed 
[Units: Participants]
 32   36   68 
Age 
[Units: Years]
Median (Full Range)
 50.5 
 (37 to 65) 
 54.5 
 (41 to 83) 
 52.5 
 (37 to 83) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      32 100.0%      36 100.0%      68 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      1   2.8%      1   1.5% 
Not Hispanic or Latino      32 100.0%      35  97.2%      67  98.5% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   32   36   68 
Tumor Size 
[Units: Participants]
Count of Participants
     
=< 2cm      2   6.3%      14  38.9%      16  23.5% 
2.1cm - 5cm      18  56.3%      11  30.6%      29  42.6% 
> 5cm      9  28.1%      9  25.0%      18  26.5% 
Inflammatory      3   9.4%      1   2.8%      4   5.9% 
Unknown      0   0.0%      1   2.8%      1   1.5% 
Lymph Node Status 
[Units: Participants]
Count of Participants
     
Node negative   1   1   2 
Node positive   31   35   66 
Endocrine Therapy During Year 1 on Study 
[Units: Participants]
Count of Participants
     
None      3   9.4%      5  13.9%      8  11.8% 
Tamoxifen or other SERM      18  56.3%      23  63.9%      41  60.3% 
Aromatase Inhibitor (AI)      5  15.6%      4  11.1%      9  13.2% 
Tamoxifen switched to AI during study year      2   6.3%      1   2.8%      3   4.4% 
No data available      4  12.5%      3   8.3%      7  10.3% 
Performance Status [1] 
[Units: Participants]
Count of Participants
     
    28  87.5%      31  86.1%      59  86.8% 
    3   9.4%      4  11.1%      7  10.3% 
Unknown      1   3.1%      1   2.8%      2   2.9% 
[1] Participants were required to have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. ECOG performance is used to assess how a participant's disease is progressing, assess how the disease affects daily living abilities, and determine appropriate treatment and prognosis. A score of 0 is "fully active, able to carry on all pre-disease performance without restriction," and 2 is "ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours."


  Outcome Measures

1.  Primary:   Change in Bone Mineral Density (BMD) From Baseline to 1 Year   [ Time Frame: Up to 1 year ]

2.  Secondary:   Rates of Metastases   [ Time Frame: Up to 1 year ]

3.  Secondary:   Overall Survival   [ Time Frame: Up to 10 years ]

4.  Secondary:   Clinical Toxicity of ZA   [ Time Frame: Up to 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Daniel Mulkerin
Organization: University of Wisconsin Carbone Cancer Center
phone: 608-265-8090
e-mail: dm2@medicine.wisc.edu



Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00213980     History of Changes
Other Study ID Numbers: CO 99103
First Submitted: September 13, 2005
First Posted: September 21, 2005
Results First Submitted: August 2, 2017
Results First Posted: January 5, 2018
Last Update Posted: January 5, 2018