Determining the Risk of Stress Fracture in IDF Soldiers Based on SNPs Identified for Osteoporosis

NCT ID: NCT03197545

Last Updated: 2017-06-23

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

UNKNOWN

Total Enrollment

440 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-30

Study Completion Date

2020-07-31

Brief Summary

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The study is a genetic historical cohort study in a military combat recruits - this study does not examine a specific treatment but rather examines a statistical link between medical history of traumatic fractures, clinical diagnosis of stress fractures and the presence of unique SNPs in subjects DNA.

Detailed Description

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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.

Conditions

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Stress Fracture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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.

No interventions assigned to this group

Traumatic fracture group

110 infantry recruits with medical history of having at least one traumatic fracture, during their life (from birth up to date).

No interventions assigned to this group

Control group

220 healthy infantry recruits never diagnosed with stress fracture or traumatic fractures

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bar-Ilan University, Israel

OTHER

Sponsor Role collaborator

Medical Corps, Israel Defense Force

OTHER

Sponsor Role lead

Responsible Party

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YEHUDA DAVID

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Izhak Haviv, Prof.

Role: STUDY_CHAIR

Bar-Ilan Faculty of Medicine, Safed

David Karasik, Prof.

Role: STUDY_DIRECTOR

Bar-Ilan Faculty of Medicine, Safed

Locations

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Bar Ilan University

Safed, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Yehuda David

Role: CONTACT

97235097773

Arnon Gam, MD

Role: CONTACT

Facility Contacts

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Yehuda David

Role: primary

97235097773

Other Identifiers

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1579-2015

Identifier Type: -

Identifier Source: org_study_id

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