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

NCT ID: NCT03742362

Last Updated: 2020-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-02

Study Completion Date

2019-12-30

Brief Summary

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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

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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.

Conditions

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Osteoporosis, Postmenopausal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

MRI scans of distal radius

Intervention Type DEVICE

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

Interventions

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MRI scans of distal radius

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role collaborator

Uri Nevo

OTHER

Sponsor Role lead

Responsible Party

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Uri Nevo

Head of the Bio-Engineering Department

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Naftali Stern, Prof

Role: PRINCIPAL_INVESTIGATOR

Sourasky Medical Center

Uri Nevo, Prof

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv University

Itzhak Binderman, Prof

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv University

Yael Schiffenbauer, PhD

Role: STUDY_DIRECTOR

Tel Aviv University

Vanessa Rouach, MD

Role: STUDY_DIRECTOR

Sourasky Medical Center

Ido Drukman, MD

Role: STUDY_DIRECTOR

Sourasky Medical Center

Locations

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Yael Schiffenbauer

Tel Aviv, , Israel

Site Status

Countries

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Israel

References

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De-Levie TK, Schiffenbauer YS, Druckmann I, Rouach V, Stern N, Binderman I, Nevo U. Quantitative MR Analysis of Changes in the Radius Bone Marrow in Osteoporosis. J Osteoporos. 2023 Dec 27;2023:7861495. doi: 10.1155/2023/7861495. eCollection 2023.

Reference Type DERIVED
PMID: 38179189 (View on PubMed)

Other Identifiers

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0090-18-TLV

Identifier Type: -

Identifier Source: org_study_id

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