Bone Structure and Strength Evaluated by Extreme-CT Scan Before and After Treatment of Hyper- and Hypothyroidism
1 other identifier
observational
93
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 3, 2013
CompletedFirst Posted
Study publicly available on registry
December 9, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedResults Posted
Study results publicly available
April 13, 2020
CompletedApril 13, 2020
April 1, 2020
4.7 years
December 3, 2013
March 6, 2020
April 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Thyroid Extreme CT
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
one year
Study Arms (2)
hyperthyroidism
61 pre- and postmenopausal women with hyperthyroidism
hypothyroidism
32 pre- and postmenopausal women with hypothyroidism
Eligibility Criteria
Women with untreated hyper- or hypothyroidism
You may qualify if:
- informed consent, female sex, age 20-85 years, indication for treatment of the thyroid disorder,
You may not qualify if:
- 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,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Steen Bonnemalead
Study Sites (1)
Odense University Hospital
Odense, 5000, Denmark
Related Publications (2)
Vinther CJ, Poulsen LH, Nicolaisen P, Obling ML, Brix TH, Hermann AP, Hegedus L, Jorgensen NR, Hansen S, Bonnema SJ. Do bone turnover markers reflect changes in bone microarchitecture during treatment of patients with thyroid dysfunction? J Endocrinol Invest. 2023 Feb;46(2):345-358. doi: 10.1007/s40618-022-01907-2. Epub 2022 Sep 5.
PMID: 36064878DERIVEDLarsen CB, Riis KR, Winther KH, Larsen EL, Ellervik C, Hegedus L, Brix TH, Poulsen HE, Bonnema SJ. Treatment of Hyperthyroidism Reduces Systemic Oxidative Stress, as Measured by Markers of RNA and DNA Damage. J Clin Endocrinol Metab. 2021 Jun 16;106(7):e2512-e2520. doi: 10.1210/clinem/dgab273.
PMID: 33901280DERIVED
Biospecimen
blood, urine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Prof. Steen Bonnema
- Organization
- Odense Universitetshospital, afd.M
Study Officials
- PRINCIPAL INVESTIGATOR
Steen Bonnema, phd, DMsci
Odense University Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Consultant, phd, DMsc
Study Record Dates
First Submitted
December 3, 2013
First Posted
December 9, 2013
Study Start
February 1, 2012
Primary Completion
October 1, 2016
Study Completion
January 1, 2020
Last Updated
April 13, 2020
Results First Posted
April 13, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share