Endocrine Function During Deferasirox Therapy

University of Campania "Luigi Vanvitelli"

Status: Completed

Conditions: Iron Overload; Endocrine; Complications; Transfusion-dependent Thalassemia

Study type: Observational

Funder types: Other

Identifiers

NCT04515680

CICL670AIT16T

Details and patient eligibility

About

A national survey on the prevalence and natural history of endocrine complications in thalassemia transfusion--dependent patients treated with deferasirox was designed, in order to assess a larger population during a longer follow up and improve the quality of previous investigations.

Enrollment: 426 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult and pediatric patients with transfusion---dependent thalassemia;
• Chelation with deferasirox as assigned chelation therapy;
• Available medical history including relevant clinical data (age at start of transfusion regimen, age at start of chelation therapy, prior chelation therapy, concomitant diseases and concomitant treatments, including hormonal replacement treatments if appropriate) and laboratory data (e.g TSH, FT3 and FT4, fasting serum glucose, OGTT serum glucose, bone mineral density z---score, T---score, g/cm2, PTH, FSH, LH, testosterone and estradiol, serum ferritin, liver function tests,renal function tests, MRI T2* value) at baseline and at the end of study

Exclusion criteria

• Non transfusion- dependent patients;
• Other chelation therapy than deferasirox or combination with other chelators during the observation;
• Absence of complete medical history as above specified