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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hyperthyroidism | 61 pre- and postmenopausal women with hyperthyroidism | ||
| hypothyroidism | 32 pre- and postmenopausal women with hypothyroidism |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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,
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Women with untreated hyper- or hypothyroidism
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| Name | Affiliation | Role |
|---|---|---|
| Steen Bonnema, phd, DMsci | Odense University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Odense | 5000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36064878 | Derived | 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. | |
| 33901280 |
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Patients are enrolled consecutively, until maximum 200 participants are reached, or further enrollment is terminated on the decision by the sponsor.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hyperthyroidism | 46 women with Graves' disease, toxic nodular goiter or subclinical hyperthyroidism |
| FG001 | Hypothyroidism | 27 women with overt or subclinical autoimmune hypothyroidism |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hyperthyroidism | 46 women with Graves' disease, toxic nodular goiter or subclinical hyperthyroidism |
| BG001 | Hypothyroidism | 27 women with overt or subclinical autoimmune hypothyroidism |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Median | Inter-Quartile Range | mm | one year |
|
19 month
Prospective monitoring and data collection of out-hospital patients during the study period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hyperthyroidism | 46 women with Graves' disease, toxic nodular goiter or subclinical hyperthyroidism |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Steen Bonnema | Odense Universitetshospital, afd.M | +4527339180 | steen.bonnema@rsyd.dk |
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| ID | Term |
|---|---|
| D006980 | Hyperthyroidism |
| D007037 | Hypothyroidism |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
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blood, urine
| Larsen 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Cortical thickness | Median | Inter-Quartile Range | mm |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 46 |
| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | Hypothyroidism | 27 women with overt or subclinical autoimmune hypothyroidism | 0 | 27 | 0 | 27 | 0 | 27 |
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| D009140 |
| Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |