zoledronate in preventing bone loss in premenopausal women receiving chemotherapy after surgery for early stage breast cancer

Conditions: Breast Cancer; Osteoporosis

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.

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.

Eligibility criteria:
disease characteristics: * diagnosis of localized breast cancer * stage i or ii (t1-3, n0-2, m0) * planned adjuvant chemotherapy (after surgery) of at least 6 months in duration * hormone receptor status: * estrogen receptor and progesterone receptor status known patient characteristics: age * 18 to 50 sex * female menopausal status * premenopausal or perimenopausal performance status * not specified life expectancy * not specified hematopoietic * not specified hepatic * not specified renal * creatinine less than 2 mg/dl other * no t score of less than 2.0 on bone mineral density (bmd) * no fragility fracture * no lumbar spine anatomy that would preclude accurate bmd measurement of a minimum of 3 lumbar vertebrae * not pregnant prior concurrent therapy: biologic therapy * not specified chemotherapy * see disease characteristics endocrine therapy * not specified radiotherapy * no concurrent radiotherapy surgery * see disease characteristics other * at least 1 month since prior calcitonin * at least 12 months since prior bisphosphonates given for more than 1 month duration * no concurrent fluoride therapy (10 mg/day or more) * no concurrent enrollment in another experimental drug study

Keywords: osteoporosis stage i breast cancer stage ii breast cancer