Spots Global Cancer Trial Database for Zoledronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy After Surgery For Early Stage Breast Cancer

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Trial Identification

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

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

Study ID: NCT00049452

Conditions

Breast Cancer

Osteoporosis

Interventions

zoledronic acid

Study Description

Brief 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.