Bone Structure and Strength Evaluated by Extreme-CT Scan Before and After Treatment of Hyper- and Hypothyroidism

• Sponsor: Steen Bonnema (Other)
• Overall Status: Completed
• CT.gov ID: NCT02005250
• Collaborator: (none)
• Enrollment: 93
• Location: 1
• Duration (Months): 95
• Patients Per Site Per Month: 1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hyperthyroidism; Hypothyroidism

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

• Study Type: Observational
• Actual Enrollment: 93 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Bone Structure and Strength Evaluated by Extreme-CT Scan Before and After Treatment of Hyper- and Hypothyroidism
• Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: Oct 1, 2016
• Actual Study Completion Date: Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
hyperthyroidism 61 pre- and postmenopausal women with hyperthyroidism
hypothyroidism 32 pre- and postmenopausal women with hypothyroidism

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: Female
• Accepts 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,

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Odense University Hospital	Odense		Denmark	5000

Sponsors and Collaborators

• Steen Bonnema

Investigators

• Principal Investigator: Steen Bonnema, phd, DMsci, Odense University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Steen Bonnema, Consultant, phd, DMsc, Odense University Hospital
• ClinicalTrials.gov Identifier: NCT02005250
• Other Study ID Numbers: Thyroid Xtreme
• First Posted: Dec 9, 2013
• Last Update Posted: Apr 13, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Steen Bonnema, Consultant, phd, DMsc, Odense University Hospital: osteoporosis; hyperthyroidism; hypothyroidism
• Additional relevant MeSH terms: Hypothyroidism; Hyperthyroidism

Study Results

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.

Arm/Group Title	Hyperthyroidism	Hypothyroidism
Arm/Group Description	46 women with Graves' disease, toxic nodular goiter or subclinical hyperthyroidism	27 women with overt or subclinical autoimmune hypothyroidism
Period Title: Overall Study
STARTED	61	32
COMPLETED	46	27
NOT COMPLETED	15	5

Baseline Characteristics

Arm/Group Title	Hyperthyroidism	Hypothyroidism	Total
Arm/Group Description	46 women with Graves' disease, toxic nodular goiter or subclinical hyperthyroidism	27 women with overt or subclinical autoimmune hypothyroidism	Total of all reporting groups
Overall Participants	46	27	73
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.83 (11.47)	48.3 (11.3)	53 (9)
Sex: Female, Male (Count of Participants)
Female	46 100%	27 100%	73 100%
Male	0 0%	0 0%	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
Denmark	46 100%	27 100%	73 100%
Cortical thickness (mm) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [mm]	0.74	1.15	0.90

Outcome Measures

1. Primary Outcome

Title	Thyroid Extreme CT
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hyperthyroidism	Hypothyroidism
Arm/Group Description	46 women with Graves' disease, toxic nodular goiter or subclinical hyperthyroidism	27 women with overt or subclinical autoimmune hypothyroidism
Measure Participants	46	27
Median (Inter-Quartile Range) [mm]	0.89	1.16

Adverse Events

Time Frame	19 month
Adverse Event Reporting Description	Prospective monitoring and data collection of out-hospital patients during the study period
Arm/Group Title	Hyperthyroidism		Hypothyroidism
Arm/Group Description	46 women with Graves' disease, toxic nodular goiter or subclinical hyperthyroidism		27 women with overt or subclinical autoimmune hypothyroidism
All Cause Mortality
	Hyperthyroidism		Hypothyroidism
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/46 (0%)		0/27 (0%)
Serious Adverse Events
	Hyperthyroidism		Hypothyroidism
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/46 (0%)		0/27 (0%)
Other (Not Including Serious) Adverse Events
	Hyperthyroidism		Hypothyroidism
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/46 (0%)		0/27 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.