NCT00049452

Zoledronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy After Surgery For Early Stage Breast Cancer

A Randomized, Placebo Controlled Trial Of Zoledronic Acid For The Prevention Of Bone Loss In Premenopausal Women With Early Stage Breast Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Herbert Irving Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: It is not yet known whether zoledronate is effective in preventing bone loss in premenopausal women who are receiving adjuvant chemotherapy after undergoing surgery for early stage breast cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of zoledronate in preventing bone loss in premenopausal women who are receiving chemotherapy after surgery for early stage breast cancer.

Detailed description

OBJECTIVES: * Compare the changes in bone mineral density (BMD) and bone turnover that occur in premenopausal women with resected early stage breast cancer during and after 6 months of adjuvant chemotherapy. * Determine the factors that predict bone loss during chemotherapy, particularly induction of amenorrhea, type of chemotherapeutic regimen, glucocorticoid exposure, and baseline BMD, in these patients. * Determine whether zoledronate prevents bone loss in these patients when given during and after adjuvant chemotherapy. * Determine the effect of zoledronate on markers of bone turnover in these patients during and after adjuvant chemotherapy. * Determine whether the effect on markers of bone turnover predicts response to zoledronate in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to estrogen receptor status (positive vs negative), progesterone receptor status (positive vs negative), and adjuvant chemotherapy regimen. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive zoledronate IV over 15 minutes on day 1. * Arm II: Patients receive placebo IV over 15 minutes on day 1. In both arms, treatment repeats every 3 months for up to 4 courses in the absence of disease progression. Patients also receive calcium and cholecalciferol (vitamin D) supplements daily. Quality of life is assessed at baseline and at 6 and 12 months. Patients are followed at 1 year. PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this study.

Conditions

• Breast Cancer
• Osteoporosis

Interventions

Type	Name	Description
DRUG	zoledronic acid

Timeline

• Start date: 2001-12-01
• Completion: 2008-08-01
• First posted: 2003-01-27
• Last updated: 2014-01-06

Locations

3 sites across 1 country: United States