Subclinical hypothyroïdismABMDPSHNCT04270110
Assessment of Bone Mineral Density in Patients With Subclinical Hypothyroidism
An observational study of Subclinical hypothyroïdism, run by Assiut University at 1 site in Egypt.
Trial summary
This study aims to recognize the effects of subclinical hypothyroidism on bone mineral density, Not many studies were done on this subject Read more about this study
- Who is it for?
- Ages Up to 55 years
- Conditions the study is for
- Subclinical hypothyroïdism
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 55 years
- All sexes
- Child, Adult
Study population: Patients: -case: patients with subclinical hypothyroidism. * control: patients with normal thyroid function
Who may be able to join
- 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).
Who cannot join
- 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
Show all 9Show fewer
- Vitamin D deficiency
- Males aged more than 55 years old
- Postmenopausal females will also be excluded in this study
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut university Hospital
Asyut, 71511Assuit
Kareem Mohammed, Master, 01140122723
About this study
This study aims to recognize the effects of subclinical hypothyroidism on bone mineral density, Not many studies were done on this subject
Read the 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.
- Conditions
- Subclinical hypothyroïdism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case | Patients with subclinical hypothyroidism | |
| Control | Patients with Normal thyroid function |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
- To detect early stages of bone affection in patients with subclinical hypothyroidism
- To detect early stages of bone affection in patients with subclinical hypothyroidism
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 Jan 2020
- Primary completion1 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subclinical hypothyroïdismStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, kareem mohammed mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270110
- Sponsor's protocol ID
- assessmentofbonemineral
- Acronym
- ABMDPSH
- Status last verified
- Jan 2020
- First submitted
- 16 Jan 2020
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 14667131
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Bone Mineral Density in Patients With Subclinical Hypothyroidism
- ClinicalTrials.gov ID
- NCT04270110
- Acronym / sponsor ID
- ABMDPSH / assessmentofbonemineral
- Conditions
- Subclinical hypothyroïdism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | –Patients with subclinical hypothyroidism |
| Control | – | –Patients with Normal thyroid function |
Who may qualify
- Ages
- Up to 55 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patients: -case: patients with subclinical hypothyroidism. * control: patients with normal thyroid function
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (9 listed)
- Diabetes mellitus
- Cushing
- hyperparathrodisim
- CKD .patients on corticosteroid therapy.
- Inflammatory conditions as rheumatoid arthritis,Systemic Lupus, Crohn's disease, ulcerative colitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
association between thyroid function parameters and bone densitometry
Time frame: 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.
1 secondary outcome
- To detect early stages of bone affection in patients with subclinical hypothyroidism
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Background: PubMed 14667131Lakatos P. Thyroid hormones: beneficial or deleterious for bone? Calcif Tissue Int. 2003 Sep;73(3):205-9. doi: 10.1007/s00223-002-0027-8.
- Thyroid Hormones: Beneficial or Deleterious for Bone?Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Subclinical hypothyroïdism
Recruiting
Additive Efficacy of Physical Activity Program in Hypthyroidism Elder Females With Glaucoma and Fatty Liver Issues
Subclinical hypothyroïdism, Non-Alcoholic Fatty Liver Disease
Recruiting
Efficay of Physical Activity Program in PCOS Females With Fatty Pancrease and Thyroid Hypofunction
Polycystic Ovary Syndrome, Non-Alcoholic Fatty Pancreatic Disease
Not yet recruitingObservational study
Relationship of Noninvasive Assessment of Central BP With 10 Years Atherosclerotic CVD in Subclinical Hypothyroidism
Subclinical hypothyroïdism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subclinical hypothyroïdism, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kareem Mohammed, Master (01032781933, kareemmohammed81993@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
association between thyroid function parameters and bone densitometry (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04270110, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.