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Bone Structure and Strength Evaluated by Extreme-CT Scan Before and After Treatment of Hyper- and Hypothyroidism

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ClinicalTrials.gov Identifier: NCT02005250
Recruitment Status : Active, not recruiting
First Posted : December 9, 2013
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Steen Bonnema, Odense University Hospital

Brief Summary:
The aim to evaluate the bone structure by Dexa-scan, extreme CT and bone markers before and one year after treatment for a thyroid functional disorder

Condition or disease
Hyperthyroidism Hypothyroidism

Detailed Description:
The aim to evaluate the bone structure by Dexa-scan, extreme CT and bone markers before and one year after treatment for a thyroid functional disorder. Women with hyper- og hypothyroidism are included and undergo usual treatment. Patients are stratified into 10 different groups.

Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bone Structure and Strength Evaluated by Extreme-CT Scan Before and After Treatment of Hyper- and Hypothyroidism
Study Start Date : February 2012
Actual Primary Completion Date : October 2017
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Graves' disease - premeno
30 premenopausal women with Graves' disease
Graves' disease - postmeno
30 postmenopausal women with Graves' disease
toxic nodular goiter - premeno
30 premenopausal women with toxic nodular goiter
toxic nodular goiter - postmeno
30 postmenopausal women with toxic nodular goiter
subclinical hyperthyroidism - premeno
30 premenopausal women with subclinical hyperthyroidism
subclinical hyperthyroidism - postmeno
30 postmenopausal women with subclinical hyperthyroidism
hypothyroidism - premeno
30 premenopausal women with hypothyroidism
hypothyroidism - postmeno
30 postmenopausal women with hypothyroidism
subclinical hypothyroidism - premeno
30 premenopausal women with subclinical hypothyroidism
subclinical hypothyroidism - postmeno
30 postmenopausal women with subclinical hypothyroidism



Primary Outcome Measures :
  1. Thyroid extreme CT [ Time Frame: one year ]
    structure of bone measured by extreme CT before and after treatment of the thyroid disorder


Biospecimen Retention:   Samples Without DNA
blood, urine


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women with untreated hyper- or hypothyroidism
Criteria

Inclusion Criteria:

informed consent, female sex, age 20-85 years, indication for treatment of the thyroid disorder,

Exclusion Criteria:

pregnancy, renal insufficiency, known osteoporosis, other disease that may affect bone metabolism, medication which affects bone metabolism, T-score below -3.5, thyroidea ophthalmopathy with indication for steroids,


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005250


Locations
Denmark
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Steen Bonnema
Investigators
Principal Investigator: Steen Bonnema, phd, DMsci Odense University Hospital

Responsible Party: Steen Bonnema, Consultant, phd, DMsc, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02005250     History of Changes
Other Study ID Numbers: Thyroid Xtreme
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Steen Bonnema, Odense University Hospital:
osteoporosis
hyperthyroidism
hypothyroidism

Additional relevant MeSH terms:
Hypothyroidism
Hyperthyroidism
Thyroid Diseases
Endocrine System Diseases