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Trial record 1 of 1 for:    NCT02005250
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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 : Completed
First Posted : December 9, 2013
Results First Posted : April 13, 2020
Last Update Posted : April 13, 2020
Sponsor:
Information provided by (Responsible Party):
Steen Bonnema, Odense University Hospital

Study Description
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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 Design
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Study Type : Observational
Actual Enrollment : 93 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 2016
Actual Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
hyperthyroidism
61 pre- and postmenopausal women with hyperthyroidism
hypothyroidism
32 pre- and postmenopausal women with hypothyroidism


Outcome Measures
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Primary Outcome Measures :
  1. Thyroid Extreme CT [ Time Frame: one year ]
    Bone cortical thickness in the radius measured by high-resolution peripheral quantitative CT, in newly diagnosed thyroid disorder, before and after treatment aimed to obtain euthyroidism


Biospecimen Retention:   Samples Without DNA
blood, urine

Eligibility Criteria
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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,

Contacts and Locations
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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
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Denmark
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Steen Bonnema
Investigators
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Principal Investigator: Steen Bonnema, phd, DMsci Odense University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Steen Bonnema, Consultant, phd, DMsc, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02005250    
Other Study ID Numbers: Thyroid Xtreme
First Posted: December 9, 2013    Key Record Dates
Results First Posted: April 13, 2020
Last Update Posted: April 13, 2020
Last Verified: April 2020
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:
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Hypothyroidism
Hyperthyroidism
Thyroid Diseases
Endocrine System Diseases