Trial Outcomes & Findings for Bone Structure and Strength Evaluated by Extreme-CT Scan Before and After Treatment of Hyper- and Hypothyroidism (NCT NCT02005250)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

93 participants

Primary outcome timeframe

one year

Results posted on

2020-04-13

Participant Flow

Patients are enrolled consecutively, until maximum 200 participants are reached, or further enrollment is terminated on the decision by the sponsor.

Participant milestones

Participant milestones
Measure	Hyperthyroidism 46 women with Graves' disease, toxic nodular goiter or subclinical hyperthyroidism	Hypothyroidism 27 women with overt or subclinical autoimmune hypothyroidism
Overall Study STARTED	61	32
Overall Study COMPLETED	46	27
Overall Study NOT COMPLETED	15	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Hyperthyroidism 46 women with Graves' disease, toxic nodular goiter or subclinical hyperthyroidism	Hypothyroidism 27 women with overt or subclinical autoimmune hypothyroidism
Overall Study Lost to Follow-up	15	5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hyperthyroidism n=46 Participants 46 women with Graves' disease, toxic nodular goiter or subclinical hyperthyroidism	Hypothyroidism n=27 Participants 27 women with overt or subclinical autoimmune hypothyroidism	Total n=73 Participants Total of all reporting groups
Age, Continuous	55.83 years STANDARD_DEVIATION 11.47 • n=46 Participants	48.3 years STANDARD_DEVIATION 11.3 • n=27 Participants	53 years STANDARD_DEVIATION 9 • n=73 Participants
Sex: Female, Male Female	46 Participants n=46 Participants	27 Participants n=27 Participants	73 Participants n=73 Participants
Sex: Female, Male Male	0 Participants n=46 Participants	0 Participants n=27 Participants	0 Participants n=73 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Denmark	46 Participants n=46 Participants	27 Participants n=27 Participants	73 Participants n=73 Participants
Cortical thickness	0.74 mm n=46 Participants	1.15 mm n=27 Participants	0.90 mm n=73 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Hyperthyroidism n=46 Participants 46 women with Graves' disease, toxic nodular goiter or subclinical hyperthyroidism	Hypothyroidism n=27 Participants 27 women with overt or subclinical autoimmune hypothyroidism
Thyroid Extreme CT	0.89 mm Interval 0.8 to 1.04	1.16 mm Interval 1.02 to 1.32

Adverse Events

Hyperthyroidism

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hypothyroidism

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Steen Bonnema

Odense Universitetshospital, afd.M

Phone: +4527339180

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place