Hyperthyroidism, Hypothyroidism
Conditions
Keywords
osteoporosis, hyperthyroidism, hypothyroidism
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
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.
Interventions
None listed
Sponsors
Steen Bonnema
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No
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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Thyroid Extreme CT | 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 |
Countries
Denmark
Participant flow
Recruitment details
Patients are enrolled consecutively, until maximum 200 participants are reached, or further enrollment is terminated on the decision by the sponsor.
Participants by arm
| Arm | Count |
|---|---|
| Hyperthyroidism 46 women with Graves' disease, toxic nodular goiter or subclinical hyperthyroidism | 46 |
| Hypothyroidism 27 women with overt or subclinical autoimmune hypothyroidism | 27 |
| Total | 73 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 15 | 5 |
Baseline characteristics
| Characteristic | Hyperthyroidism | Hypothyroidism | Total |
|---|---|---|---|
| Age, Continuous | 55.83 years STANDARD_DEVIATION 11.47 | 48.3 years STANDARD_DEVIATION 11.3 | 53 years STANDARD_DEVIATION 9 |
| Cortical thickness | 0.74 mm | 1.15 mm | 0.90 mm |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Denmark | 46 Participants | 27 Participants | 73 Participants |
| Sex: Female, Male Female | 46 Participants | 27 Participants | 73 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 27 |
| other Total, other adverse events | 0 / 46 | 0 / 27 |
| serious Total, serious adverse events | 0 / 46 | 0 / 27 |
Outcome results
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
Time frame: one year
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hyperthyroidism | Thyroid Extreme CT | 0.89 mm |
| Hypothyroidism | Thyroid Extreme CT | 1.16 mm |