Osteoporosis, PostmenopausalNCT03742362
MRI Study of the Distal Radius Bone Marrow Fat Fraction in Osteoporotic and Healthy Women
A study testing MRI scans of distal radius in people with Osteoporosis, Postmenopausal, run by Uri Nevo at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Postmenopausal
- What is being tested?
- MRI scans of distal radius
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteIsrael
- Study dates
- 2 Feb 2019to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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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Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Osteoporosis, Postmenopausal
- Being tested
- MRI scans of distal radius
- Keywords
- Osteoporosis, MRI, distal radius, postmenopausal
- Medical subject headings
- Osteoporosis, Postmenopausal, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scans of distal radiusDevice
MRI scans to monitor the fat fraction in the bone marrow of the distal radius
| Study group | Role | What they receive |
|---|---|---|
| Bone marrow fat fraction by MRI | Experimental | MRI scans of distal radius will be performed to all participants to monitor the fat fraction in bone marrow Receives: Device: MRI scans of distal radius |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat fraction in bone marrow
The bone marrow will be studied to determine the percentage of fat
Measured: 30 min- 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start2 Feb 2019
- Primary completion30 Aug 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uri Nevo
- Sponsor type
- University, hospital or other
- Collaborators
- Tel-Aviv Sourasky Medical Center
- Responsible party
- Sponsor-investigator, Uri Nevo, Tel Aviv University
- Investigators
- Naftali Stern, Prof, Principal investigator, Sourasky Medical CenterUri Nevo, Prof, Principal investigator, Tel Aviv UniversityItzhak Binderman, Prof, Principal investigator, Tel Aviv UniversityYael Schiffenbauer, PhD, Study director, Tel Aviv UniversityVanessa Rouach, MD, Study director, Sourasky Medical CenterIdo Drukman, MD, Study director, Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03742362
- Sponsor's protocol ID
- 0090-18-TLV
- Status last verified
- Mar 2020
- First submitted
- 11 Nov 2018
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38179189
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Study of the Distal Radius Bone Marrow Fat Fraction in Osteoporotic and Healthy Women
- ClinicalTrials.gov ID
- NCT03742362
- Acronym / sponsor ID
- 0090-18-TLV
- Conditions
- Osteoporosis, Postmenopausal
- Keywords
- Osteoporosis, MRI, distal radius, postmenopausal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Uri NevoUniversity, hospital or other
- Collaborators
- Tel-Aviv Sourasky Medical Center
- Study start
- 2 Feb 2019 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 15 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Bone marrow fat fraction by MRI | Experimental | Device: MRI scans of distal radiusMRI scans of distal radius will be performed to all participants to monitor the fat fraction in bone marrow |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI scans of distal radiusMRI scans to monitor the fat fraction in the bone marrow of the distal radius | Device | Bone marrow fat fraction by MRI |
Primary outcome
Fat fraction in bone marrow
Time frame: 30 min- 1 hour
The bone marrow will be studied to determine the percentage of fat
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Derived from this study: PubMed 38179189De-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naftali Stern, Prof principal investigator
Sourasky Medical Center
Uri Nevo, Prof principal investigator
Tel Aviv University
Itzhak Binderman, Prof principal investigator
Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI scans of distal radius in people with Osteoporosis, Postmenopausal, run by Uri Nevo at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat fraction in bone marrow (time frame: 30 min- 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03742362, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.