RATIONALE: Zoledronate may reduce bone loss in patients receiving letrozole for breast cancer. PURPOSE: This clinical trial is studying how well zoledronate works in treating osteopenia or osteoporosis in postmenopausal women receiving letrozole for stage I, stage II, or stage IIIA primary breast cancer.
OBJECTIVES: Primary * Assess changes in total lumbar spine bone mineral density (BMD) from baseline to 12 months in postmenopausal women treated with zoledronate for osteopenia or osteoporosis and letrozole for hormone receptor-positive, stage I-IIIA primary breast cancer. Secondary * Determine changes in total lumbar spine BMD from baseline to 2, 3, 4, and 5 years in these patients. * Determine changes in femoral neck BMD from baseline to 1, 2, 3, 4, and 5 years in these patients. * Determine time to disease progression in these patients. OUTLINE: This is an open-label, multicenter study. * Adjuvant aromatase inhibitor therapy: Patients receive oral letrozole daily for up to 5 years in the absence of disease progression or unacceptable toxicity. * Osteoporosis management: Patients receive zoledronate IV over 15 minutes on day 1. Patients also receive oral elemental calcium twice daily and oral vitamin D daily for 6 months. Treatment repeats every 6 months for up to 5 years in the absence of disease progression or unacceptable toxicity. Patients undergo total lumbar spine and hip (femoral neck) bone density testing by dual energy x-ray absorptiometry (DXA) at baseline and annually for 5 years. After completion of study therapy, patients are followed at 4 weeks. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
60
zoledronic acid
standard care
Mayo Clinic in Florida
Jacksonville, Florida, United States
Mayo Clinic
Rochester, Minnesota, United States
Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD)
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
Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) at Year 2 Post Study Entry
Change: BMD values at year 2 post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.
Time frame: Baseline and 2 year
Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) at Year 3 Post Study Entry
Change: BMD values at year 3 post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.
Time frame: Baseline and 3 year
Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) at Year 4 Post Study Entry
Change: BMD values at year 4 post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.
Time frame: Baseline and 4 year
Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) at Year 5 Post Study Entry
Change: BMD values at year 5 post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.
Time frame: Baseline and 5 year
Average Intra-patient Change in Femoral Neck Bone Mineral Density (BMD) at Year 1 Post Study Entry
Change: BMD values at year 1 post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline and 1 year
Average Intra-patient Change in Femoral Neck Bone Mineral Density (BMD) at Year 2 Post Study Entry
Change: BMD values at year 2 post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.
Time frame: Baseline and 2 year
Average Intra-patient Change in Femoral Neck Bone Mineral Density (BMD) at Year 3 Post Study Entry
Change: BMD values at year 3 post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.
Time frame: Baseline and 3 year
Average Intra-patient Change in Femoral Neck Bone Mineral Density (BMD) at Year 4 Post Study Entry
Change: BMD values at year 4 post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.
Time frame: Baseline and 4 year
Average Intra-patient Change in Femoral Neck Bone Mineral Density (BMD) at Year 5 Post Study Entry
Change: BMD values at year 5 post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.
Time frame: Baseline and 5 year
Maximum-Grade Toxicity Incidence at Least Possibly Related to Study Medications
Adverse events were assessed per NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. Grade 1=Mild, Grade 2=Moderate.
Time frame: 5 years
Time to Disease Progression
Time to disease progression was defined as the time from date of randomization to the documentation of disease progression.
Time frame: Up to 5 years