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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03742362
Enrollment
26
Registered
2018-11-15
Start date
2019-02-02
Completion date
2019-12-30
Last updated
2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis, Postmenopausal

Keywords

Osteoporosis, MRI, distal radius, postmenopausal

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.

Interventions

DEVICEMRI scans of distal radius

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

Sponsors

Tel-Aviv Sourasky Medical Center
CollaboratorOTHER_GOV
Uri Nevo
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

3 groups of women: Group 1: Healthy young women Group 2: Postmenopausal women without Osteoporosis Group 3: Postmenopausal women with Osteoporosis All will undergo the same MRI scans

Eligibility

Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
Yes

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. \-

Design outcomes

Primary

MeasureTime frameDescription
Fat fraction in bone marrow30 min- 1 hourThe bone marrow will be studied to determine the percentage of fat

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026