Clinical trial NCT04270110: Assessment of Bone Mineral Density in Patients With Subclinical Hypothyroidism
Official title: Assessment of Bone Mineral Density in Patients With Subclinical Hypothyroidism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Subclinical hypothyroïdism
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 100
Sex: ALL
Maximum age (years): 55
Standard ages: CHILD
ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients: -case: patients with subclinical hypothyroidism.

* control: patients with normal thyroid function

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: association between thyroid function parameters and bone densitometry
timeFrame: 1 year
Secondary outcomes:
measure: - To detect early stages of bone affection in patients with subclinical hypothyroidism
timeFrame: 1 year
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: Assiut university Hospital
Study officials:
References:
citation: 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.