NCT03951818

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 9, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 15, 2019

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

5 years

First QC Date

May 9, 2019

Last Update Submit

February 16, 2021

Conditions

Thalassemia Major

Outcome Measures

Primary Outcomes (1)

  • Abnormal bone mineral density rate

    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.

    10 years

Secondary Outcomes (2)

  • abnormal thyroid function rate

    10 years

  • abnormal pituitary function rate

    10 years

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

20-85 years old thalassemia major patients treated in the OPD of NTUH

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shyang-Rong Shih

Taipei, 100, Taiwan

RECRUITING

Related Publications (1)

  • 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):dgz309. doi: 10.1210/clinem/dgz309.

    PMID: 31907538DERIVED

MeSH Terms

Conditions

beta-Thalassemia

Condition Hierarchy (Ancestors)

ThalassemiaAnemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Shyang-Rong Shih, MD, PhD

    National Taiwan University Hospital

    STUDY DIRECTOR

Central Study Contacts

Shyang-Rong Shih, MD, PhD

CONTACT

+886-972653337srshih@ntu.edu.tw

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2019

First Posted

May 15, 2019

Study Start

April 1, 2019

Primary Completion

April 1, 2024

Study Completion

April 1, 2024

Last Updated

February 18, 2021

Record last verified: 2021-02

Locations

TW(1)