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

This study is currently recruiting participants.
Verified June 2016 by Steen Bonnema, Odense University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02005250
First Posted: December 9, 2013
Last Update Posted: June 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Steen Bonnema, Odense University Hospital
  Purpose
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
Hyperthyroidism Hypothyroidism

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Steen Bonnema, Odense University Hospital:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 300
Study Start Date: February 2012
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
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
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


Contacts
Contact: Steen Bonnema, phd, DMsc steen.bonnema@rsyd.dk

Locations
Denmark
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Steen Bonnema    +4565413437    steen.bonnema@rsyd.dk   
Principal Investigator: Steen Bonnema         
Sponsors and Collaborators
Steen Bonnema
Investigators
Principal Investigator: Steen Bonnema, phd, DMsci Odense University Hospital
  More Information

Responsible Party: Steen Bonnema, Consultant, phd, DMsc, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02005250     History of Changes
Other Study ID Numbers: Thyroid Xtreme
First Submitted: December 3, 2013
First Posted: December 9, 2013
Last Update Posted: June 7, 2016
Last Verified: June 2016
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