Assessment of Bone Mineral Density in Patients With Subclinical Hypothyroidism
ABMDPSH
1 other identifier
observational
100
1 country
1
Brief Summary
This study aims to recognize the effects of subclinical hypothyroidism on bone mineral density, Not many studies were done on this subject
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2020
CompletedFirst Submitted
Initial submission to the registry
January 16, 2020
CompletedFirst Posted
Study publicly available on registry
February 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedFebruary 17, 2020
January 1, 2020
11 months
January 16, 2020
February 12, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
association between thyroid function parameters and bone densitometry
association of Subclinical hypothyroidism which represents a state with increased values of thyroid stimulating hormone (TSH) and normal values of thyroxine (T4) and triiodothyronine (T3). The disorder is asymptomatic, and the diagnosis is made based on the results of laboratory findings when the level of TSH reaches values above 4.0 mU/ with osteoporesis disorder on bone densitometry. Dual x-ray absorptiometry (DXA) is currently the standard for assessing bone mineral density (BMD), in this study dxa scan will be used on the forearm to assess T score and Z score.
1 year
Secondary Outcomes (1)
- To detect early stages of bone affection in patients with subclinical hypothyroidism
1 year
Study Arms (2)
Case
Patients with subclinical hypothyroidism
Control
Patients with Normal thyroid function
Eligibility Criteria
Patients: -case: patients with subclinical hypothyroidism. * control: patients with normal thyroid function
You may qualify if:
- \- All adult patients with subclinical hypothyroidism with the level of TSH values above 4.0 mU/l.and normal values of thyroxine (T4) and triiodothyronine (T3).
You may not qualify if:
- Diabetes mellitus
- Cushing
- hyperparathrodisim
- CKD .patients on corticosteroid therapy.
- Inflammatory conditions as rheumatoid arthritis,Systemic Lupus, Crohn's disease, ulcerative colitis
- Haematological conditions as multiple myeloma, Myeloproliferative disorders
- Vitamin D deficiency
- Males aged more than 55 years old
- Postmenopausal females will also be excluded in this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut university Hospital
Asyut, 71511Assuit, Egypt
Related Publications (1)
Lakatos P. Thyroid hormones: beneficial or deleterious for bone? Calcif Tissue Int. 2003 Sep;73(3):205-9. doi: 10.1007/s00223-002-0027-8.
PMID: 14667131BACKGROUND
Related Links
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- resident doctor
Study Record Dates
First Submitted
January 16, 2020
First Posted
February 17, 2020
Study Start
January 1, 2020
Primary Completion
December 1, 2020
Study Completion
December 31, 2021
Last Updated
February 17, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share