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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03742362
Other study ID # 0090-18-TLV
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2, 2019
Est. completion date December 30, 2019

Study information

Verified date March 2020
Source Tel Aviv University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date December 30, 2019
Est. primary completion date August 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 45 Years to 65 Years
Eligibility 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.

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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.

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Study Design


Related Conditions & MeSH terms


Intervention

Device:
MRI scans of distal radius
MRI scans to monitor the fat fraction in the bone marrow of the distal radius

Locations

Country Name City State
Israel Yael Schiffenbauer Tel Aviv

Sponsors (2)

Lead Sponsor Collaborator
Uri Nevo Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fat fraction in bone marrow The bone marrow will be studied to determine the percentage of fat 30 min- 1 hour
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