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IntroductionThe aim of this multicenter, phase III, prospective open label clinical trial was to investigate the effect of risedronate (R) on bone mineral density (BMD) in postmenopausal, early breast cancer (BC) patients scheduled to receive anastrozole (A).MethodsPre-treatment BMD of 213 patients with hormone receptor-positive BC was evaluated at lumbar spine (LS) and hip (HP). Patients were categorized according to their baseline BMD T-score as being at low, moderate and high risk of osteoporosis. Low risk patients received anastrozole only (A), moderate risk were randomized to anastrozole +/- risedronate (A+/-R) administration and high risk patients received anastrozole + risedronate (A+R). Anastrozole was given at a dosage of 1 mg/day while oral risedronate was given at 35 mg/week. BMD was then assessed at 12 and 24 months. All patients received daily supplements of calcium (1000 mg/day) and vitamin D (400 IU/day).ResultsAt 24 months, in the moderate risk group, treatment with A+R resulted in a significant increase in BMD at LS and HP compared to treatment with A only (5.7% v -1.5%, Wilcoxon test P = 0.006, and 1.6% v -3.9% Wilcoxon test P = 0.037, respectively), while no significant difference was found at 12 months; 24.3% of the patients moved to normal BMD region. In the high risk group, a significant increase for LS was detected both at 12 and 24 months (6.3% and 6.6%, P < 0.001) but not for HP; BMD in 14% of patients improved to the osteopenic region. In the low risk group, a significant decrease of BMD was detected at 12 months for LS and HP (-5.3% P < 0.001 and -2.4% P < 0.001, respectively,); at 24 months, a significant decrease of BMD was detected only for LS (-2.5%, P < 0.001). However, 22% of patients became osteopenic and only 4% became osteoporotic.ConclusionsThe addition of oral risedronate in post-menopausal breast cancer patients receiving anastrozole has a favorable effect on BMD. Patients with pre-treatment osteopenic to osteoporotic status should be treated with a combination of both therapies in order to avoid bone loss induced by aromatase inhibition. Patients with normal BMD before starting treatment with anastrozole have a very low risk to develop osteoporosis.Trial registrationClinicalTrials.gov Identifier NCT00809484.

Introduction Extended adjuvant endocrine therapy for breast cancer with aromatase inhibitors may potentially alter the lipid profile of postmenopausal patients and thus increase the risk of developing cardiovascular disease. In this study, a subprotocol of the ATENA (Adjuvant post-Tamoxifen Exemestane versus Nothing Applied) trial, we compared the effect of the steroidal aromatase inactivator exemestane on the lipid profile of postmenopausal patients with operable breast cancer, in the adjuvant setting, with that of observation alone after completion of 5 to 7 years of primary treatment with tamoxifen.

PurposeWe investigated whether age at anastrozole (A) initiation influences the effect of treatment on bone mineral density (BMD). We conducted a post hoc analysis of the dataset of Arimidex Bone Mass Index Oral Bisphosphonates prospective trial, studying the effect of risedronate (R) on BMD of postmenopausal, early breast cancer patients receiving A.MethodsPatients were stratified into those with normal BMD or mild osteopenia (T > −2) receiving A-only and patients with mild or severe osteopenia (T ≤ −2) or osteoporosis (T < −2.5) receiving A and per os R (A + R). Depending on age on treatment initiation, patients were grouped into two age cohorts, above and below 65 years. BMD change in lumbar spine (LS) and hip (HP) was evaluated at 12 months. An analysis of patients with normal BMD at baseline was additionally performed.ResultsAmong patients receiving A-only, women ≤65 years were more likely to have a decrease in LS-BMD than older (p = 0.034). HP-BMD decrease at 12 months was not related to age (p = 0.182). In patients with mild or severe osteopenia or osteoporosis, treated with A + R, no age effect was observed for LS or HP (p = 0.099 and p = 0.939, respectively). Among patients with normal BMD at baseline, the age effect on LS-BMD change was more profound (p = 0.026).ConclusionsOur study suggests that younger postmenopausal women with normal BMD or mild osteopenia receiving A-only face an increased risk of bone loss in LS. Among patients with mild or severe osteopenia or osteoporosis treated with A + R, 12 months LS or HP BMD variations were configured regardless of age group.

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