Phase 2 placebo-controlled, single-blind trial to evaluate the impact of oral ibandronate on bone mineral density in osteopenic breast cancer patients receiving adjuvant aromatase inhibitors: 5-year results of the single-centre BONADIUV trial
European Journal of Cancer Feb 09, 2019
Livi L, et al. - Researchers report the finally concluded outcomes of the BONADIUV trial, a single-blind, randomised, placebo-controlled phase 2 study to assess the influence of ibandronate treatment on bone mineral density (BMD) in osteopenic women taking aromatase inhibitors (AI). Using randomization in a 1:1 ratio, either placebo or oral monthly ibandronate (150 mg) was administered to 171 osteopenic patients, aged 60.2 years (range 44–75), between 2011 and 2014. Patients were treated for 2 years, with 6-month evaluation. At a 5-year median follow-up, survival outcomes were assessed via secondary analyses. They noted 97.5% and 93.0% of overall survival (OS) rate in the placebo group and in the ibandronate arm, respectively, at a median follow-up of 63.3 months. Overall, improved BMD change was observed in association with treatment with ibandronate vs placebo in osteopenic women treated with adjuvant AI. Findings of 5-year survival analyses revealed no disparate OS and invasive disease-free survival rates between arms.
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