HyperthyroidismNCT02005250
Bone Structure and Strength Evaluated by Extreme-CT Scan Before and After Treatment of Hyper- and Hypothyroidism
An observational study of Hyperthyroidism and Hypothyroidism, run by Steen Bonnema at 1 site in Denmark.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Hyperthyroidism, Hypothyroidism
- How many people
- 93 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2012to 1 Jan 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with untreated hyper- or hypothyroidism
Who may be able to join
- informed consent, female sex, age 20-85 years, indication for treatment of the thyroid disorder,
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Hyperthyroidism, Hypothyroidism
- Keywords
- osteoporosis, hyperthyroidism, hypothyroidism
- Medical subject headings
- Hyperthyroidism, Hypothyroidism, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| hyperthyroidism | 61 pre- and postmenopausal women with hyperthyroidism | |
| hypothyroidism | 32 pre- and postmenopausal women with hypothyroidism |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startFeb 2012
- Primary completionOct 2016
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HyperthyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steen Bonnema
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Steen Bonnema, Odense University Hospital
- Investigators
- Steen Bonnema, phd, DMsci, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005250
- Sponsor's protocol ID
- Thyroid Xtreme
- Status last verified
- Apr 2020
- First submitted
- 3 Dec 2013
- Last updated
- 13 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 36064878Larsen 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.
PubMed 33901280
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Structure and Strength Evaluated by Extreme-CT Scan Before and After Treatment of Hyper- and Hypothyroidism
- ClinicalTrials.gov ID
- NCT02005250
- Acronym / sponsor ID
- Thyroid Xtreme
- Conditions
- Hyperthyroidism, Hypothyroidism
- Keywords
- osteoporosis, hyperthyroidism, hypothyroidism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Steen BonnemaUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Oct 2016 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 9 Dec 2013 (estimated)
- Results
- Posted 13 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyperthyroidism | – | –61 pre- and postmenopausal women with hyperthyroidism |
| hypothyroidism | – | –32 pre- and postmenopausal women with hypothyroidism |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with untreated hyper- or hypothyroidism
Key inclusion criteria (1 listed)
- informed consent, female sex, age 20-85 years, indication for treatment of the thyroid disorder,
Key exclusion criteria (1 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36064878Vinther 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.
- Derived from this study: PubMed 33901280Larsen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steen Bonnema, phd, DMsci principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperthyroidism and Hypothyroidism, run by Steen Bonnema at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thyroid Extreme CT (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02005250, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2020.