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MRI Study of the Distal Radius Bone Marrow Fat Fraction in Osteoporotic and Healthy Women

U

Uri Nevo

Status

Completed

Conditions

Osteoporosis, Postmenopausal

Treatments

Device: MRI scans of distal radius

Study type

Interventional

Funder types

Other

Identifiers

NCT03742362
0090-18-TLV

Details and patient eligibility

About

The aim of the study is to test whether the distal radius bone marrow show significant difference in the fat fraction in young women compared to post menopausal women with and without osteoporosis.

Full description

Patients of the Department of Endocrinology, who routinely perform bone density tests, DXA (Dual Energy X-ray absorpiometry) test on the lumbar spine, proximal femoral and distal radius, will be invited for a visit, and after signing the informed consent form, the following data will be collected: age, BMI, first menstrual period and last menstrual period, family history of osteoporosis, history of osteoporotic fractures, smoking, alcohol use and exercise habits. In addition, blood tests will be performed: calcium phosphate, albumin, alkaline phosphatase, vitamin D level, thyroid function, LH (Luteinizing Hormone) FSH (Follicle Stimulating Hormone), Estradiol, and serum bone turnover index (CTX P1NP). Amount of blood taken: 12 ml The patients will then be sent to the Alfredo Federico Strauss Center for Computerized Neuroimaging at Tel Aviv University for an MRI study of the distal radius. The study results will be analyzed by an expert bone radiologist from the Sourasky Medical Center to reject any kind of pathology (such as a fracture, inflammation, tumor), and further analyzed for bone marrow fat fraction by Tel Aviv University researchers. In the case of abnormal findings, they will be mentioned in the report and the participants will receive recommendations from the appropriate expert.

Enrollment

26 patients

Sex

Female

Ages

45 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Women over the age of 45 with regular menstruation should be included in group 1, women over the age of 55 without menstruation for at least one year should be included in groups 2 or 3 according to the results of the bone density test. If T-Score> -2.5 will be included in group 2 and if T-Score <-2.5 they will be included in group 3.

Exclusion Criteria: Women with metabolic bone disease, thyroid or pre-thyroid disease, diabetes, chronic steroid use, use of osteoporosis drugs, hormonal therapy, BMI below 20 or over 27, pregnant women and tattooed women in the area under study will not be included in the study.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

26 participants in 1 patient group

Bone marrow fat fraction by MRI
Experimental group
Description:
MRI scans of distal radius will be performed to all participants to monitor the fat fraction in bone marrow
Treatment:
Device: MRI scans of distal radius

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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