Endocrine; Complications, Iron Overload, Transfusion-dependent Thalassemia
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
University of Campania Luigi Vanvitelli
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline number of endocrine disorders at study completion | baseline through study completion, a minimum of 5 years | Absolute change in number of patients diagnosed with any endocrine disorder at the baseline and at the study completion |
Countries
Italy
Outcome results
None listed