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

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.

Study Overview

• Status: Completed
• Conditions: Osteoporosis, Postmenopausal
• Intervention / Treatment: Device: MRI scans of distal radius

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel, 6085001
    • Yael Schiffenbauer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bone marrow fat fraction by MRI; MRI scans of distal radius will be performed to all participants to monitor the fat fraction in bone marrow	Device: MRI scans of distal radius; MRI scans to monitor the fat fraction in the bone marrow of the distal radius

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fat fraction in bone marrow	The bone marrow will be studied to determine the percentage of fat	30 min- 1 hour

Collaborators and Investigators

• Sponsor: Uri Nevo
• Collaborators: Tel-Aviv Sourasky Medical Center
• Investigators: Principal Investigator: Naftali Stern, Prof, Sourasky Medical Center; Principal Investigator: Uri Nevo, Prof, Tel Aviv University; Principal Investigator: Itzhak Binderman, Prof, Tel Aviv University; Study Director: Yael Schiffenbauer, PhD, Tel Aviv University; Study Director: Vanessa Rouach, MD, Sourasky Medical Center; Study Director: Ido Drukman, MD, Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2019
• Primary Completion (Actual): August 30, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: November 11, 2018
• First Submitted That Met QC Criteria: November 14, 2018
• First Posted (Actual): November 15, 2018

Study Record Updates

• Last Update Posted (Actual): March 3, 2020
• Last Update Submitted That Met QC Criteria: March 1, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: MRI; Osteoporosis; postmenopausal; distal radius
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Osteoporosis, Postmenopausal
• Other Study ID Numbers: 0090-18-TLV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No