Assessment of Bone Mineral Density in Patients With Subclinical Hypothyroidism

Subclinical hypothyroïdism Clinical Trial

— ABMDPSH  

Official title:

Assessment of Bone Mineral Density in Patients With Subclinical Hypothyroidism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04270110
• Other study ID #: assessmentofbonemineral
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2020
• Source: Assiut University
• Contact: Kareem Mohammed, Master
• Phone: 01032781933
• Email: kareemmohammed81993[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to recognize the effects of subclinical hypothyroidism on bone mineral density, Not many studies were done on this subject

Description:

A lot of different factors are necessary for the harmonious development as well as normal functioning of skeleton: genetic conditions, hormonal and metabolic homeostasis, balanced diet, mechanical load. Any disturbances of those agents can lead to serious and dangerous consequences like length reduction, deformations, and fractures. Their results depend, between other, on one's age, type of disorder and its duration.

• There are a lot of endocrinological reasons of secondary osteoporosis (for example:

Cushing's syndrome, hyperparathyroidism, hypogonadism, acromegaly, diabetes mellitus, hypothyroidism etc..

Any changes of normal thyroid function and Thyroid stimulating hormones (TSH) directly affects the remodeling of bone through TSH receptor found on osteoblast and osteoclast precursor cells.

TSH has a positive correlation with body mass index (BMI) in women; though, this correlation is insignificant in male. Women having subclinical hypothyroidism have reduced femoral neck bone mineral density (BMD). The variations in thyroid function are primary, while changes in body weight and bones are secondary. The physiological variation of thyroid hormones is associated with changes in BMD and non vertebral fracture risk in healthy postmenopausal women.

The definition of osteoporosis by the world health organization (WHO) is densitometric and non-clinical and is based on the measurement of bone mass and dexa method in the spine or hip. There is still controversy about the relation between thyroid hormones, osteoporosis and BMD in female hypothyroid patients. This study aims to fill the gaps in our understanding of impact of subclinical hypothyroid disorder on bone densitometry.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2021
• Est. primary completion date: December 1, 2020
• Gender: All
• Age group: N/A to 55 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hypothyroidism
• Subclinical hypothyroïdism

Locations

Country	Name	City	State
Egypt	Assiut university Hospital	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Lakatos P. Thyroid hormones: beneficial or deleterious for bone? Calcif Tissue Int. 2003 Sep;73(3):205-9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	- To detect early stages of bone affection in patients with subclinical hypothyroidism	- To detect early stages of bone affection in patients with subclinical hypothyroidism	1 year

External Links

•   Thyroid Hormones: Beneficial or Deleterious for Bone?