Zoledronate in Treating Osteopenia or Osteoporosis in Postmenopausal Women Receiving Letrozole for Stage I, Stage II, or Stage IIIA Primary Breast Cancer
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.
Drug: zoledronic acid
Procedure: Letrozole as adjuvant therapy
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Zoledronic Acid for Treatment of Osteopenia and Osteoporosis in Women With Primary Breast Cancer Undergoing Adjuvant Aromatase Inhibitor (Letrozole) Therapy|
- Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]Change: BMD values at twelve months post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.
- Total Lumbar Spine BMD as Measured by DXA at Baseline and at 24, 36, 48, and 60 > Months [ Time Frame: 5 yr ] [ Designated as safety issue: No ]
- Femoral Neck BMD as Measured by DXA at Baseline and at 12, 24, 36, 48, and 60 Months [ Time Frame: 5 yr ] [ Designated as safety issue: No ]
- Frequency and Severity of Toxicity as Assessed by NCI CTCAE v3.0 [ Time Frame: 5 yr ] [ Designated as safety issue: No ]
- Time to Disease Progression [ Time Frame: 5 yr ] [ Designated as safety issue: No ]
|Study Start Date:||April 2006|
|Estimated Study Completion Date:||February 2013|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Experimental: 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.
Drug: zoledronic acid
Other Name: Zometa®Procedure: Letrozole as adjuvant therapy
Other Name: Femara®
- 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 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.
|United States, Florida|
|Mayo Clinic in Florida|
|Jacksonville, Florida, United States, 32224|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Stephanie Hines, MD||Mayo Clinic in Florida|
|Principal Investigator:||Charles L. Loprinzi, MD||Mayo Clinic|