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ABMDPSH: Assessment of Bone Mineral Density in Patients With Subclinical Hypothyroidism

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04270110
Collaborator
(none)
100
Enrollment
1
Location
24
Anticipated Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Assessment of Bone Mineral Density in Patients With Subclinical Hypothyroidism
    Actual Study Start Date :
    Jan 1, 2020
    Anticipated Primary Completion Date :
    Dec 1, 2020
    Anticipated Study Completion Date :
    Dec 31, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Case

    Patients with subclinical hypothyroidism
    Control

    Patients with Normal thyroid function

    Outcome Measures

    Primary Outcome Measures

    1. association between thyroid function parameters and bone densitometry [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.

    Secondary Outcome Measures

    1. - To detect early stages of bone affection in patients with subclinical hypothyroidism [1 year]

      - To detect early stages of bone affection in patients with subclinical hypothyroidism

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 55 Years
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut university Hospital Assuit Egypt 71511Assuit

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    kareem mohammed mohammed, resident doctor, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04270110
    Other Study ID Numbers:
    • assessmentofbonemineral
    First Posted:
    Feb 17, 2020
    Last Update Posted:
    Feb 17, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypothyroidism

    Study Results

    No Results Posted as of Feb 17, 2020