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Zoledronate in Treating Osteopenia or Osteoporosis in Postmenopausal Women Receiving Letrozole for Stage I, Stage II, or Stage IIIA Primary Breast Cancer

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ClinicalTrials.gov Identifier: NCT00436917
Recruitment Status : Completed
First Posted : February 19, 2007
Results First Posted : August 12, 2011
Last Update Posted : April 18, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Breast Cancer
Osteoporosis
Interventions Drug: zoledronic acid
Procedure: Letrozole as adjuvant therapy
Enrollment 60

Recruitment Details Sixty participants were recruited between June 2006 and July 2007 at 6 individual sites participating in the Mayo Clinic Cancer Research Consortium (MCCRC).
Pre-assignment Details  
Arm/Group Title Zoledronic Acid
Hide Arm/Group Description 4 mg intravenously over 15 minutes every 6 months (until disease progression or for 5 years)
Period Title: Overall Study
Started 54 [1]
Completed 0
Not Completed 54
Reason Not Completed
Withdrawal by Subject             6
Adverse Event             1
Still on treatment             47
[1]
6 participants with cancellation, protocol violation and ineligible were excluded from all analysis.
Arm/Group Title Zoledronic Acid
Hide Arm/Group Description 4 mg intravenously over 15 minutes every 6 months (until disease progression or for 5 years)
Overall Number of Baseline Participants 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants
66.7  (10.13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
Female
54
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   3.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   1.9%
White
51
  94.4%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Prior tamoxifen  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 54 participants
Yes 24
No 30
Duration of tamoxifen use  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 54 participants
Missing 30
<=2 years 4
>2 years 20
Time since tamoxifen ended  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 54 participants
Missing 30
<1 year 20
>=1 year 4
Prior chemotherapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 54 participants
Yes 21
No 33
Previous fracture by history or X-ray  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 54 participants
Yes 7
No 47
Bone Mineral Density Measurement in Lumbar Spine   [1] 
Mean (Standard Deviation)
Unit of measure:  G/cm2
Number Analyzed 54 participants
0.86  (0.12)
[1]
Measure Description: Baseline bone mineral density measurement in lumbar spine for the 30 participants analyzed in primary analysis.
1.Primary Outcome
Title Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD)
Hide Description Change: BMD values at twelve months post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.
Time Frame Baseline and 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The primary analysis is performed on data where participants had the same baseline and 1 year BMD Lumbar Spine measurement location (L1-L4, L2-L4 or ‘other Lumbar Spine’)
Arm/Group Title Zoledronic Acid
Hide Arm/Group Description:
4 mg intravenously over 15 minutes every 6 months (until disease progression or for 5 years)
Overall Number of Participants Analyzed 30
Mean (95% Confidence Interval)
Unit of Measure: Percentage of the baseline value
2.66
(1.27 to 4.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zoledronic Acid
Comments A sample of 60 participants was estimated to provide percentage statistics accuracy to within 13% with 95% confidence.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
2.Secondary Outcome
Title Total Lumbar Spine BMD as Measured by DXA at Baseline and at 24, 36, 48, and 60 > Months
Hide Description [Not Specified]
Time Frame 5 yr
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Femoral Neck BMD as Measured by DXA at Baseline and at 12, 24, 36, 48, and 60 Months
Hide Description [Not Specified]
Time Frame 5 yr
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Frequency and Severity of Toxicity as Assessed by NCI CTCAE v3.0
Hide Description [Not Specified]
Time Frame 5 yr
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Time to Disease Progression
Hide Description [Not Specified]
Time Frame 5 yr
Outcome Measure Data Not Reported
Time Frame Adverse event data were collected within the first year of the study.
Adverse Event Reporting Description One participant was excluded from adverse event reporting due to the adverse event data was not available beyond the baseline time point.
 
Arm/Group Title Zoledronic Acid
Hide Arm/Group Description 4 mg intravenously over 15 minutes every 6 months (until disease progression or for 5 years)
All-Cause Mortality
Zoledronic Acid
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Zoledronic Acid
Affected / at Risk (%) # Events
Total   0/53 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Zoledronic Acid
Affected / at Risk (%) # Events
Total   35/53 (66.04%)    
Gastrointestinal disorders   
Nausea  1  4/53 (7.55%)  4
Vomiting  1  1/53 (1.89%)  1
General disorders   
Fatigue  1  1/53 (1.89%)  1
Fever-No ANC  1  3/53 (5.66%)  3
Investigations   
Creatinine  1  1/53 (1.89%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia  1  31/53 (58.49%)  53
Nervous system disorders   
Headache  1  1/53 (1.89%)  1
Psychiatric disorders   
Depression  1  1/53 (1.89%)  1
Skin and subcutaneous tissue disorders   
Rash/Desquamation  1  1/53 (1.89%)  1
Vascular disorders   
Hot flashes  1  2/53 (3.77%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Stephanie L. Hines, M.D.
Organization: Mayo Clinic Jacksonville
Phone: 507-266-0800
Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00436917     History of Changes
Other Study ID Numbers: MC05C8
P30CA015083 ( U.S. NIH Grant/Contract )
MC05C8 ( Other Identifier: Mayo Clinic Cancer Center )
2330-05 ( Other Identifier: Mayo Clinic IRB )
First Submitted: February 15, 2007
First Posted: February 19, 2007
Results First Submitted: July 19, 2011
Results First Posted: August 12, 2011
Last Update Posted: April 18, 2017