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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Odense University Hospital
Sponsor:
Information provided by (Responsible Party):
Steen Bonnema, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT02005250
First received: December 3, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  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 Odense University Hospital:

Primary Outcome Measures:
  • Thyroid extreme CT [ Time Frame: one year ] [ Designated as safety issue: No ]
    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: March 2016
Estimated Primary Completion Date: March 2015 (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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Steen Bonnema, Consultant, phd, DMsc, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02005250     History of Changes
Other Study ID Numbers: Thyroid Xtreme
Study First Received: December 3, 2013
Last Updated: December 3, 2013
Health Authority: Denmark: Danish Health and Medicines Authority

Keywords provided by Odense University Hospital:
osteoporosis
hyperthyroidism
hypothyroidism

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

ClinicalTrials.gov processed this record on September 29, 2014