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Evaluation of ICL670, a once-daily oral iron chelator in a phase III clinical trial of beta-thalassemia patients with transfusional iron overload.

Author(s): Galanello R

Affiliation(s): Ospedale Regionale Microcitemie, Via Jenner s/n, 09121 Cagliari, Sardinia, Italy. renzo.galanello@mcweb.unica.it

Publication date & source: 2005, Ann N Y Acad Sci., 1054:183-5.

Publication type: Clinical Trial, Phase III; Comparative Study ; Multicenter Study; Randomized Controlled Trial

Osteoporosis and osteopenia are frequent complications of thalassemia major (TM) and intermedia (TI). Osteoporosis was found in 23/25 patients with TI and in 115/239 patients with TM. In TM, no association was found with specific polymorphisms in candidate genes (vitamin D receptor, estrogen receptor, calcitonin receptor, and collagen type 1 alpha 1). Osteoporosis in TM female was strongly associated with primary amenorrhea (P < .0001), while in male patients with TM hypogonadism was not significantly related to BMD (P = .0001). Low BMD was also associated with cardiomiopathy (P = .01), diabetes mellitus (P = .0001), chronic hepatitis (P = .0029), and increased ALT (P = .01).

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