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Old 05-20-2014, 07:40 AM   #1
'lizbeth
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Post oral bisphosphonate treatment on bone mineral density in osteopenic women receiving a

A single-blind, randomized, placebo-controlled phase II study to evaluate the impact of oral bisphosphonate treatment on bone mineral density in osteopenic women receiving adjuvant aromatase inhibitors: Interim analysis of “BONADIUV” trial.



Abstract No:
TPS658
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2014 ASCO Annual Meeting!


Session: Breast Cancer - HER2/ER
Type: General Poster Session
Time: Monday June 2, 8:00 AM to 11:45 AM
Location: S Hall A2
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Author(s): Vieri Scotti, Icro Meattini, Sara Cecchini, Maria Laura De Feo, Calogero Saieva, Carla De Luca Cardillo, Lorenzo Livi; Florence University Hospital, Florence, Italy; Empoli Hospital, Empoli, Italy; ISPO Florence Cancer Center, Florence, Italy
Abstract Disclosures

Abstract:

Background: Aromatase inhibitors (AIs) are a highly effective well-tolerated treatment for post-menopausal endocrine-responsive breast cancer (BC). However, their use is associated with accelerated bone loss and increased risk of fractures. The ARIBON trial published by Lester et al in 2008 showed that monthly oral ibandronate improves bone density and normalizes bone turnover in patients treated with anastrozole. BONADIUV trial is a single-blind, randomized, placebo-controlled phase II study designed to evaluate the impact of oral ibandronate (150 mg monthly) on bone mineral density (BMD) in osteopenic women on AIs in adjuvant setting. Methods: All patients underwent histological proven diagnosis of BC. Patients received breast surgery and adjuvant treatment according to clinical and pathological status at Our Institute. Enrolled patients were candidate to 5 years of adjuvant AIs. Major exclusion criteria were: previous diagnosis of solid tumors, psychiatric disorders, premenopausal status, smokers patients, chronic use of steroids, ipertyroidism, iperparathyroidism, rheumatoid arthritis, severe thinness (body mass index <16), age less than 18 years or more than 70. All patients were treated with vitamin D supplementation for an overall treatment of 24 months. The primary endpoint was the change in BMD at lumbar spine or hip after 12 and 24 months of treatment in ibandronate-treated patients (Arm A) compared with those receiving placebo (Arm B). Patients were also stratified by menopausal age, body mass index and age. Secondary end points included adverse events monitoring. Common Terminology Criteria for Adverse Events (CTCAE) 4.0 were utilized to record toxicity related events. Recruiting is ongoing: 105 of planned 196 patients have been enrolled. Fifty-three patients were allocated in arm A and 52 patients were allocated in arm B. At 12 months’ follow up visit, complete data were assessable in 86 cases. At 24 months’ follow up visit, complete data were assessable in 40 patients.
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