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

Primary Purpose

Osteoporosis, Postmenopausal

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

MRI scans of distal radius

About this trial

This is an interventional other trial for Osteoporosis, Postmenopausal focused on measuring Osteoporosis, MRI, distal radius, postmenopausal

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

Yael Schiffenbauer

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bone marrow fat fraction by MRI

Arm Description

MRI scans of distal radius will be performed to all participants to monitor the fat fraction in bone marrow

Outcomes

Primary Outcome Measures

Fat fraction in bone marrow

The bone marrow will be studied to determine the percentage of fat

Secondary Outcome Measures

Full Information

NCT ID

NCT03742362

First Posted

November 11, 2018

Last Updated

March 1, 2020

Sponsor

Uri Nevo

Collaborators

Tel-Aviv Sourasky Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03742362

Brief Title

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

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

February 2, 2019 (Actual)

Primary Completion Date

August 30, 2019 (Actual)

Study Completion Date

December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Uri Nevo

Collaborators

Tel-Aviv Sourasky Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis, Postmenopausal

Keywords

Osteoporosis, MRI, distal radius, postmenopausal

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bone marrow fat fraction by MRI

Arm Type

Experimental

Arm Description

MRI scans of distal radius will be performed to all participants to monitor the fat fraction in bone marrow

Intervention Type

Device

Intervention Name(s)

MRI scans of distal radius

Intervention Description

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

Primary Outcome Measure Information:

Title

Fat fraction in bone marrow

Description

The bone marrow will be studied to determine the percentage of fat

Time Frame

30 min- 1 hour

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Female

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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. - 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. -

Overall Study Officials: