Conditions: Breast Cancer Osteoporosis
Keywords: stage I breast cancer stage II breast cancer stage IIIA breast cancer osteoporosis
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 60
Healthy volunteers: no

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.

Arms:
arm 1: 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.

Interventions: intervention 1: zoledronic acid intervention 2: Letrozole as adjuvant therapy
Intervention descriptions: intervention 1: zoledronic acid intervention 2: standard care

Protocol document: