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出境医 / 临床实验 / Observing the Changes of Endocrine and Metabolism in Patients With Thalassemia Major

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

Study Description
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.

Condition or disease
Thalassemia Major

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Observing the Changes of Endocrine and Metabolism in Patients With Thalassemia Major
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 1, 2024
Estimated Study Completion Date : April 1, 2024
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Abnormal bone mineral density rate [ Time Frame: 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 :
  1. abnormal thyroid function rate [ Time Frame: 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.

  2. abnormal pituitary function rate [ Time Frame: 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)


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
20-85 years old thalassemia major patients treated in the OPD of NTUH
Criteria

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
Contacts and Locations

Contacts
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Contact: Shyang-Rong Shih, MD, PhD +886-972653337 srshih@ntu.edu.tw

Locations
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Taiwan
Shyang-Rong Shih Recruiting
Taipei, Taiwan, 100
Contact: Shyang-Rong Shih    886-23123456    srshih@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Study Director: Shyang-Rong Shih, MD, PhD National Taiwan University Hospital
Tracking Information
First Submitted Date May 9, 2019
First Posted Date May 15, 2019
Last Update Posted Date February 18, 2021
Actual Study Start Date April 1, 2019
Estimated Primary Completion Date April 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 14, 2019) 		Abnormal bone mineral density rate [ Time Frame: 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 14, 2019)
  • abnormal thyroid function rate [ Time Frame: 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 [ Time Frame: 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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Observing the Changes of Endocrine and Metabolism in Patients With Thalassemia Major
Official Title Observing the Changes of Endocrine and Metabolism in Patients With Thalassemia Major
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 Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 20-85 years old thalassemia major patients treated in the OPD of NTUH
Condition Thalassemia Major
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Yang WP, Chang HH, Li HY, Lai YC, Huang TY, Tsai KS, Lin KH, Lin DT, Jou ST, Lu MY, Yang YL, Chou SW, Shih SR. Iron Overload Associated Endocrine Dysfunction Leading to Lower Bone Mineral Density in Thalassemia Major. J Clin Endocrinol Metab. 2020 Apr 1;105(4). pii: dgz309. doi: 10.1210/clinem/dgz309.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 14, 2019) 		100
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 1, 2024
Estimated Primary Completion Date April 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Shyang-Rong Shih, MD, PhD +886-972653337 srshih@ntu.edu.tw
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03951818
Other Study ID Numbers 201903041RINB
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor National Taiwan University Hospital
Collaborators Not Provided
Investigators
Study Director: Shyang-Rong Shih, MD, PhD National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date February 2021

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