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Assessment of Bone Mineral Density in Patients With Subclinical Hypothyroidism (ABMDPSH)

A

Assiut University

Status

Unknown

Conditions

Subclinical hypothyroïdism

Study type

Observational

Funder types

Other

Identifiers

NCT04270110
assessmentofbonemineral

Details and patient eligibility

About

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

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

Under 55 years old

Volunteers

No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Case
Description:
Patients with subclinical hypothyroidism
Control
Description:
Patients with Normal thyroid function

Trial contacts and locations

1

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Central trial contact

Kareem Mohammed, Master

Data sourced from clinicaltrials.gov

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