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

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

Study Overview

• Status: Unknown
• Conditions: Subclinical hypothyroïdism

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Egypt
  • Assuit, Egypt, 71511Assuit
    • Recruiting
    • Assiut University Hospital
    • Contact: Kareem Mohammed, Master; Phone Number: 01140122723

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 55 years (ADULT, CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients: -case: patients with subclinical hypothyroidism.

• control: patients with normal thyroid function

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Case; Patients with subclinical hypothyroidism
Control; Patients with Normal thyroid function

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
- 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

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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.

Helpful Links

• Thyroid Hormones: Beneficial or Deleterious for Bone?

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2020
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: January 16, 2020
• First Submitted That Met QC Criteria: February 12, 2020
• First Posted (ACTUAL): February 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 12, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases; Hypothyroidism
• Other Study ID Numbers: assessmentofbonemineral

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No