Clinical trial NCT03742362: MRI Study of the Distal Radius Bone Marrow Fat Fraction in Osteoporotic and Healthy Women
Official title: MRI Study of the Distal Radius Bone Marrow Fat Fraction in Osteoporotic and Healthy Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis, Postmenopausal
Keywords: Osteoporosis
MRI
distal radius
postmenopausal
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
Collaborators: name: Tel-Aviv Sourasky Medical Center
First posted: 2018-11-15
Enrollment: 26
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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
Primary purpose: OTHER

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.

Eligibility 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.

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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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Primary outcomes:
measure: Fat fraction in bone marrow
timeFrame: 30 min- 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Yael Schiffenbauer
Study officials:
affiliation: Sourasky Medical Center
name: Naftali Stern, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Tel Aviv University
name: Uri Nevo, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Tel Aviv University
name: Itzhak Binderman, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Tel Aviv University
name: Yael Schiffenbauer, PhD
role: STUDY_DIRECTOR
affiliation: Sourasky Medical Center
name: Vanessa Rouach, MD
role: STUDY_DIRECTOR
affiliation: Sourasky Medical Center
name: Ido Drukman, MD
role: STUDY_DIRECTOR
References: