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临床试验/NCT04270110
NCT04270110Unknown不适用

Assessment of Bone Mineral Density in Patients With Subclinical Hypothyroidism

Assiut University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
association between thyroid function parameters and bone densitometry

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
— 至 55 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • Diabetes mellitus
  • 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

结局指标

主要结局

association between thyroid function parameters and bone densitometry

时间窗: 1 year

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.

次要结局

  • - To detect early stages of bone affection in patients with subclinical hypothyroidism(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

kareem mohammed mohammed

resident doctor

Assiut University

研究点 (1)

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