There is a controversy about effect of treatment of subclinical hyperthyroidism (suppressed TSH with normal FT4 and FT3) on bone mineral density. This study investigates effects of treatment of subclinical hyperthyroidism with oral anti-thyroid drugs on bone mineral density of young (premenopausal) women that are at risk of postmenopausal osteoporosis. Thirty eligible patients referred to Kurdistan nuclear medicine center for thyroid function study, which have suppressed TSH and normal FT4 & FT3 will be selected. These patients shouldn’t have any history of thyroid disorders or any cause of secondary osteoporosis. They are randomly divided into two groups of 15 patients. One group is treated with oral anti-thyroid drug (methimazole). Both treated and observed groups are followed for 1 year with periodic thyroid function testing. The treated group should be euthyroid and the observed group should stay with subclinical hyperthyroidism for 1 year. Bone mineral density of femoral neck and lumbar vertebrae are measured by DXA method in both groups at the beginning of the study and after 1 year. Changes in BMDs of the observed and treated groups after one year are compared to determine any statistically significant differences between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138809012750N1
Registration date:2010-05-11, 1389/02/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-05-11, 1389/02/21
Registrant information
Name
Siamak Derakhshan
Name of organization / entity
Kurdestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 1328 2532
Email address
siamak.derakhshan@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan university of medical sciences
Expected recruitment start date
2009-05-05, 1388/02/15
Expected recruitment end date
2010-05-05, 1389/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of antithyroid drug therapy on bone mineral density of young women with endogenous subclinical hyperthyroidism
Public title
Effects of antithyroid drug therapy on bone mineral density of young women with endogenous subclinical hyperthyroidism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Young women referred to Kurdistan nuclear medicine center for thyroid evaluation which has suppressed TSH and normal FT4 and FT3 without history of thyroid disorders.
Exclusion criteria: Secondary osteoporosis, hypersensitivity to oral anti-thyroid drugs, discontinuation of 1 year follow-up
Age
From 15 years old to 55 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kurdistan medical university
Street address
Pasdaran boulevard-in front of Shadi hotel
City
Sanandaj
Postal code
Approval date
empty
Ethics committee reference number
668/پ/14/پ
Health conditions studied
1
Description of health condition studied
Subclinical hyperthyroidism
ICD-10 code
E05.9
ICD-10 code description
Thyrotoxicosis, unspecified Hyperthyroidism NOS
Primary outcomes
1
Description
Thyroid function
Timepoint
3-6-12 months after treatment
Method of measurement
TSH, freeT3, freeT4 measurement by IRMA & RIA methods
Secondary outcomes
1
Description
Bone mineral density
Timepoint
12 months after treatment or follow-up
Method of measurement
Measuring BMD of lumbar vertebrae(L2-L4) and femoral neck by DXA method
Intervention groups
1
Description
Intervention: Methimazole 5-10 mg/day po until the patient become euthyroid then 2.5-5 mg/day po maintenace dose for 1 year.
Category
Treatment - Drugs
2
Description
Control: Without any intervention for 1 year
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kurdistan nuclear medicine center
Full name of responsible person
Siamak Derakhshan M.D
Street address
No.26 Golbarg alley Abidar avenue
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kurdistan university of medical sciences
Full name of responsible person
Fardin Gharibi
Street address
Pasdaran boulevard,in front of Shadi Hotel
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?