- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03197545
Determining the Risk of Stress Fracture in IDF Soldiers Based on SNPs Identified for Osteoporosis
Study Overview
Status
Conditions
Detailed Description
Finding a statistically significant correlation between SNPs associated with BMD - Osteoporosis, with recruits who were diagnosed with Stress Fractures during basic and advanced infantry training. Greatest importance will be shown in the power calculation: we suggest that the P-value threshold value of the selected SNPs be adjusted downwards to a lower threshold of P <1.0x10-3 (i.e. equal to 50 independent tests).
We will examine the presence or absence of 96 SNPs - 76 SNPs that were previously validated as significant with low BMD or Osteoporosis and 20 SNPs offered for Stress Fractures with recruits who were diagnosed with Stress Fractures during basic training (basic training lasts four months - six months) using SNP Genotyping Analysis-TaqMan Assays. The buccal swab will be taken from recruits who served for at least four months and up to six months in the IDF - Infantry Corps. Buccal swabs will be taken at a single meeting from recruits serving between 4 and 6 months in the IDF - Infantry Corps, which will be used to compare using SNP Genotyping Analysis-TaqMan Assays with the SNPs listed above. In addition, in this single meeting, the recruits will fill out a questionnaire in which they will be asked whether they experienced traumatic fracture from their youth to the time of filling the questionnaire (recruits who experienced traumatic fractures but are not diagnosed with stress fractures constitute as a control group in the research).
There will be one meeting with recruiters who served for at least four months and up to six months in the IDF - infantry. At this meeting, the recruits will be sampled with a buccal swab and fill out a questionnaire.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Yehuda David
- Phone Number: 97235097773
- Email: yehuda13@gmail.com
Study Contact Backup
- Name: Arnon Gam, MD
- Email: dr.gam@hotmail.com
Study Locations
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Safed, Israel
- Recruiting
- Bar Ilan University
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Contact:
- Yehuda David
- Phone Number: 97235097773
- Email: yehuda13@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All participants (440) in the research are male.
- All participants (440) are recruits who serve 4-6 months in the IDF - infantry - basic training.
- 110 recruits with a stress fracture diagnosis in their medical portfolio.
- 110 recruits who have Section 4161x flaw (section Eclipse: a long bone fracture)
- 220 recruits without the aforementioned impairment clause and the above mentioned diagnosis (referred as control group).
Exclusion Criteria:
- Recruit who left the unit before conducting the research.
- A recruiter who did not complete his training due to a course that lasted over two weeks while carrying out basic training.
- A recruiter who did not complete his basic training due to absenteeism.
- A recruiter who has not completed his basic training due to problems with the service conditions.
- A recruiter who has not completed his basic training due to the reduction of a medical profile.
- A recruiter who did not complete his basic training due to a decrease in the recruitment cycle.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Stress fracture group
110 recruits diagnosed (clinicaly and/or by imaging) with at least one stress fracture, during basic and advanced infantry trainig.
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Traumatic fracture group
110 infantry recruits with medical history of having at least one traumatic fracture, during their life (from birth up to date).
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Control group
220 healthy infantry recruits never diagnosed with stress fracture or traumatic fractures
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Finding a statistically significant correlation between SNPs associated with BMD - Osteoporosis, with recruits who were diagnosed with Stress Fractures during basic and advanced infantry training.
Time Frame: There will be one meeting with recruiters who served for at least four months and up to six months in the IDF - infantry. At this meeting, the recruits will be sampled with a buccal swab and fill out a questionnaire.
|
We will examine the presence or absence of 96 SNPs - 76 SNPs that were previously validated as significant with low BMD or Osteoporosis and 20 SNPs offered for Stress Fractures with recruits who were diagnosed with Stress Fractures during basic training (basic training lasts four months - six months) using SNP Genotyping Analysis-TaqMan Assays.
The buccal swab will be taken from recruits who served for at least four months and up to six months in the IDF - Infantry Corps.
Buccal swabs will be taken at a single meeting from recruits serving between 4 and 6 months in the IDF - Infantry Corps
|
There will be one meeting with recruiters who served for at least four months and up to six months in the IDF - infantry. At this meeting, the recruits will be sampled with a buccal swab and fill out a questionnaire.
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Izhak Haviv, Prof., Bar-Ilan Faculty of Medicine, Safed
- Study Director: David Karasik, Prof., Bar-Ilan Faculty of Medicine, Safed
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1579-2015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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