Observing the Changes of Endocrine and Metabolism in Patients With Thalassemia Major

• Conditions: Thalassemia Major

• Registration Number: NCT03951818
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

Patient with thalassemia major have many endocrine diseases, such as hypopituitarism, hypothyroidism, hypoparathyroidis, osteoporosis, and etc.. These problems may be due to anemia itself or related to iron deposition. This study aimed to investigate the endocrine aspect of thalassemia major patients in Taiwan in order to introduce early intervention or treatment in the future.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2019-05-09
• Study First Submitted QC: 2019-05-14
• Study First Posted: 2019-05-15
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-18
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Clinical diagnosis of Thalassemia major
• Patients of 20-85 years old

Exclusion Criteria

• Patients younger than 20 years old.
• Patients older than 85 years old.
• Patients who are pregnant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Abnormal bone mineral density rate	10 years	abnormal bone mineral density is defined as T-score \< -1 SD in menopause women or men older than 50 years old, or Z score \< -2 SD in premenopausal women or men not older than 50 year old.

Secondary Outcome Measures

Name	Time	Method
abnormal thyroid function rate	10 years	abnormal thyroid function is defined as abnormal free thyroxine or abnormal thyrotropin. Normal range of free thyroxine is 0.6-1.75 ng/dl. normal range of thyrotropin is 0.1-4.5 mU/l.
abnormal pituitary function rate	10 years	abnormal pituitary function is defined as any of the abnormality in serum adrenocorticotropin (pg/l), IGF-1 (ng/ml). thyrotropin (mU/l), FSH (U/l), LH (U/l)

Trial Locations

Locations (1)

Shyang-Rong Shih; 🇨🇳 Taipei, Taiwan