Bone effects of exemestane versus tamoxifen within the TEAM Trial: Results of a prospective randomized bone substudy

572 Background: A prospective open label randomized multicenter trial was performed in the German TEAM Trial Group to compare the effects of exemestane (EXE) and tamoxifen (TAM) on bone mineral density (BMD) and markers of bone turnover during adjuvant treatment of postmenopausal women with estrogen receptor-positive breast cancer. Methods: BMD and markers of bone turnover were assessed at baseline, after 6 and 12 months of treatment. BMD was performed using dual x-ray absorptiometry (DXA). Marker of bone formation (PINP), bone specific alkaline phosphatase (BAP) and osteocalcin (OC) as well as bone resorption marker (ICPM) were analysed using standardised methods. Intent-to-treat analysis was performed based on 200 patients. The primary endpoint was to compare exemestane and tamoxifen with regard to changes from baseline to month 12 in spine BMD. Results: 156 patients with a mean age of 61 yr. (± 7.3 yr.) were available for final analysis. Both groups were comparable regarding age, height, tumor grade an...