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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03742362
Recruitment Status : Completed
First Posted : November 15, 2018
Last Update Posted : March 3, 2020
Sponsor:
Collaborator:
Tel-Aviv Sourasky Medical Center
Information provided by (Responsible Party):
Uri Nevo, Tel Aviv University

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.

Condition or disease Intervention/treatment Phase
Osteoporosis, Postmenopausal Device: MRI scans of distal radius Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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
Masking: None (Open Label)
Primary Purpose: Other
Official Title: MRI Study of the Distal Radius Bone Marrow Fat Fraction in Osteoporotic and Healthy Women
Actual Study Start Date : February 2, 2019
Actual Primary Completion Date : August 30, 2019
Actual Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

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




Primary Outcome Measures :
  1. Fat fraction in bone marrow [ Time Frame: 30 min- 1 hour ]
    The bone marrow will be studied to determine the percentage of fat



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   Yes
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03742362


Locations
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Israel
Yael Schiffenbauer
Tel Aviv, Israel, 6085001
Sponsors and Collaborators
Uri Nevo
Tel-Aviv Sourasky Medical Center
Investigators
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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
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Responsible Party: Uri Nevo, Head of the Bio-Engineering Department, Tel Aviv University
ClinicalTrials.gov Identifier: NCT03742362    
Other Study ID Numbers: 0090-18-TLV
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Uri Nevo, Tel Aviv University:
Osteoporosis
MRI
distal radius
postmenopausal
Additional relevant MeSH terms:
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Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases