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

Not Applicable

Completed

• Conditions: Osteoporosis, Postmenopausal

• Registration Number: NCT03742362
• Lead Sponsor: Uri Nevo

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-11-11
• Study First Submitted QC: 2018-11-14
• Study First Posted: 2018-11-15
• Study Start: 2019-02-02
• Primary Completion: 2019-08-30
• Study Completion: 2019-12-30
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-01
• Last Update Posted: 2020-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Fat fraction in bone marrow	30 min- 1 hour	The bone marrow will be studied to determine the percentage of fat

Trial Locations

Locations (1)

Yael Schiffenbauer; 🇮🇱 Tel Aviv, Israel