Denosumab in transfusion-dependent thalassemia osteoporosis: a randomized, placebo-controlled, double-blind phase 2b clinical trial by Ersi Voskaridou,

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Denosumab in transfusion-dependent thalassemia osteoporosis: a randomized, placebo-controlled, double-blind phase 2b clinical trial by Ersi Voskaridou, Ioannis Ntanasis-Stathopoulos, Athanasios Papaefstathiou, Dimitrios Christoulas, Maria Dimopoulou, Konstantina Repa, Athanasios Papatheodorou, Melpomeni Peppa, and Evangelos Terpos BloodAdv Volume 2(21):2837-2847 November 13, 2018 © 2018 by The American Society of Hematology

Ersi Voskaridou et al. Blood Adv 2018;2:2837-2847 © 2018 by The American Society of Hematology

Study schema. Study schema. On enrolment in the study after eligibility assessment, patients were randomly assigned in a 1:1 fashion to receive either 60 mg DNM or placebo sc, every 6 months for 12 months for a total of 2 doses (Day 0 ± 3 and Day 180 ± 3). Patients were followed every 3 months for clinical and laboratory evaluation. Ersi Voskaridou et al. Blood Adv 2018;2:2837-2847 © 2018 by The American Society of Hematology

Consort flow diagram. Consort flow diagram. Among the 80 patients assessed for eligibility, 63 were eventually randomized: 32 were allocated to and received DNM, whereas 31 were allocated to and received placebo. One patient from the placebo group was lost to follow-up, whereas 2 patients from the DNM group withdrew consent. The final analysis was made on an intent-to-treat basis. Ersi Voskaridou et al. Blood Adv 2018;2:2837-2847 © 2018 by The American Society of Hematology

Analysis of covariance for the bone mineral density percentage change, defined as the dependent variable, with treatment group as a factor, defined as the independent variable consisting of 2 levels (DNM and placebo), and first baseline T score as covariate or nuisance variable. Analysis of covariance for the bone mineral density percentage change, defined as the dependent variable, with treatment group as a factor, defined as the independent variable consisting of 2 levels (DNM and placebo), and first baseline T score as covariate or nuisance variable. A significant difference on the percentage change (from baseline to 12-month visit) between the 2 groups was observed, after adjusting for the baseline T score (P = .043). DNM induced a significantly greater increase in bone mineral density compared with placebo. Ersi Voskaridou et al. Blood Adv 2018;2:2837-2847 © 2018 by The American Society of Hematology