BONADIUV trial: A single blind, randomized placebo controlled phase II study using oral ibandronate for osteopenic women receiving adjuvant aromatase inhibitors: Final safety analysis.

Abstract

e12043Background: Aromatase inhibitors (AI) are a highly effective treatment for postmenopausal hormonal positive status breast cancer (BC). However its use is associated with accelerated bone loss and potential increase in treatment related adverse events. We present the final analysis concerning trial safety results. Methods: We enrolled between 2011 and 2014 osteopenic early BC patients candidate to 3-5 years of adjuvant AI. All patients were treated with vitamin D supplementation, for an overall treatment of 24 months. Patients were also stratified by menopausal age, body mass index and age. Adverse events monitoring was a secondary endpoint of trial. Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized to record toxicity events. We performed different stratified analysis for bisphosphonate-related, AI-related, and overall symptoms incidence rates. The primary endpoint of the trial was the change in BMD at lumbar spine or hip after 12 and 24 months of follow up. Recruiting ...