Zoledronate in Treating Osteopenia or Osteoporosis in Postmenopausal Women Receiving Letrozole for Stage I, Stage II, or Stage IIIA Primary Breast Cancer
- Conditions
- OsteoporosisBreast Cancer
- Interventions
- Procedure: Letrozole as adjuvant therapy
- Registration Number
- NCT00436917
- Lead Sponsor
- Mayo Clinic
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description zoledronic acid Letrozole as adjuvant therapy 4 mg 15 minutes IV infusion. If creatinine clearance is ≤ 60, dosage should be adjusted as follows:CrCl 50-60: 3.5 mg; CrCl 40-49: 3.3 mg; CrCl 30-39: 3.0 mg. zoledronic acid zoledronic acid 4 mg 15 minutes IV infusion. If creatinine clearance is ≤ 60, dosage should be adjusted as follows:CrCl 50-60: 3.5 mg; CrCl 40-49: 3.3 mg; CrCl 30-39: 3.0 mg.
- Primary Outcome Measures
Name Time Method Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) Baseline and 1 year Change: BMD values at twelve months post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.
- Secondary Outcome Measures
Name Time Method Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) at Year 2 Post Study Entry Baseline and 2 year Change: BMD values at year 2 post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.
Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) at Year 4 Post Study Entry Baseline and 4 year Change: BMD values at year 4 post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.
Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) at Year 3 Post Study Entry Baseline and 3 year Change: BMD values at year 3 post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.
Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) at Year 5 Post Study Entry Baseline and 5 year Change: BMD values at year 5 post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.
Average Intra-patient Change in Femoral Neck Bone Mineral Density (BMD) at Year 2 Post Study Entry Baseline and 2 year Change: BMD values at year 2 post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.
Maximum-Grade Toxicity Incidence at Least Possibly Related to Study Medications 5 years Adverse events were assessed per NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. Grade 1=Mild, Grade 2=Moderate.
Average Intra-patient Change in Femoral Neck Bone Mineral Density (BMD) at Year 1 Post Study Entry Baseline and 1 year Change: BMD values at year 1 post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.
Average Intra-patient Change in Femoral Neck Bone Mineral Density (BMD) at Year 3 Post Study Entry Baseline and 3 year Change: BMD values at year 3 post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.
Average Intra-patient Change in Femoral Neck Bone Mineral Density (BMD) at Year 4 Post Study Entry Baseline and 4 year Change: BMD values at year 4 post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.
Average Intra-patient Change in Femoral Neck Bone Mineral Density (BMD) at Year 5 Post Study Entry Baseline and 5 year Change: BMD values at year 5 post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.
Time to Disease Progression Up to 5 years Time to disease progression was defined as the time from date of randomization to the documentation of disease progression.
Trial Locations
- Locations (2)
Mayo Clinic in Florida
🇺🇸Jacksonville, Florida, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States