Zoledronic Acid for Treatment of Osteopenia and Osteoporosis in Women With Primary Breast Cancer Undergoing Adjuvant Aromatase Inhibitor (Letrozole) Therapy
- 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.
- Determine changes in total lumbar spine BMD from baseline to 2, 3, 4, and 5 years in
- Determine changes in femoral neck BMD from baseline to 1, 2, 3, 4, and 5 years in these
- 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.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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.
Baseline and 1 year
Stephanie Hines, MD
Mayo Clinic in Florida
United States: Food and Drug Administration
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