Thalassemia MajorNCT03951818
Observing the Changes of Endocrine and Metabolism in Patients With Thalassemia Major
An observational study of Thalassemia Major, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Thalassemia Major
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2019to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 20-85 years old thalassemia major patients treated in the OPD of NTUH
Who may be able to join
- Clinical diagnosis of Thalassemia major
- Patients of 20-85 years old
Who cannot join
- Patients younger than 20 years old.
- Patients older than 85 years old.
- Patients who are pregnant
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Shyang-Rong Shih
Taipei, 100
Shyang-Rong Shih, 886-23123456, srshih@ntu.edu.tw
About this study
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.
- Conditions
- Thalassemia Major
- Medical subject headings
- beta-Thalassemia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Secondary outcomes (2)
abnormal thyroid function rate
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.
Measured: 10 years
abnormal pituitary function rate
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)
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start1 Apr 2019
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thalassemia MajorStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shyang-Rong Shih, MD, PhD, Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03951818
- Sponsor's protocol ID
- 201903041RINB
- Status last verified
- Feb 2021
- First submitted
- 9 May 2019
- Last updated
- 18 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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):dgz309. doi: 10.1210/clinem/dgz309.
PubMed 31907538
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observing the Changes of Endocrine and Metabolism in Patients With Thalassemia Major
- ClinicalTrials.gov ID
- NCT03951818
- Acronym / sponsor ID
- 201903041RINB
- Conditions
- Thalassemia Major
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 15 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 20-85 years old thalassemia major patients treated in the OPD of NTUH
Key inclusion criteria (2 listed)
- Clinical diagnosis of Thalassemia major
- Patients of 20-85 years old
Key exclusion criteria (3 listed)
- Patients younger than 20 years old.
- Patients older than 85 years old.
- Patients who are pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
abnormal thyroid function rate
Time frame: 10 years
abnormal pituitary function rate
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Derived from this study: PubMed 31907538Yang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shyang-Rong Shih, MD, PhD study director
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thalassemia Major, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shyang-Rong Shih, MD, PhD (+886-972653337, srshih@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abnormal bone mineral density rate (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03951818, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.