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

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ClinicalTrials.gov Identifier: NCT03197545
Recruitment Status : Recruiting
First Posted : June 23, 2017
Last Update Posted : June 23, 2017
Sponsor:
Collaborator:
Bar-Ilan University, Israel
Information provided by (Responsible Party):
YEHUDA DAVID, Medical Corps, Israel Defense Force

Brief Summary:
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.

Condition or disease
Stress Fracture

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.


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Study Type : Observational
Estimated Enrollment : 440 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Determining the Risk of Stress Fracture in IDF Soldiers Based on SNPs Identified for Osteoporosis
Estimated Study Start Date : June 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Stress fracture group
110 recruits diagnosed (clinicaly and/or by imaging) with at least one stress fracture, during basic and advanced infantry trainig.
Traumatic fracture group
110 infantry recruits with medical history of having at least one traumatic fracture, during their life (from birth up to date).
Control group
220 healthy infantry recruits never diagnosed with stress fracture or traumatic fractures



Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
DNA samples will be taken by a sample of the patient's saliva from the inside of the cheek by a sterile specific kit designed for the preservation and subsequent production of DNA from the kit (FTA card).


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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
440 male infantry recruits training in an IDF (the Israel Defense Forces) boot camp in Israel
Criteria

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.

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): NCT03197545


Contacts
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Contact: Yehuda David 97235097773 yehuda13@gmail.com
Contact: Arnon Gam, MD dr.gam@hotmail.com

Locations
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Israel
Bar Ilan University Recruiting
Safed, Israel
Contact: Yehuda David    97235097773    yehuda13@gmail.com   
Sponsors and Collaborators
Medical Corps, Israel Defense Force
Bar-Ilan University, Israel
Investigators
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Study Chair: Izhak Haviv, Prof. Bar-Ilan Faculty of Medicine, Safed
Study Director: David Karasik, Prof. Bar-Ilan Faculty of Medicine, Safed

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Responsible Party: YEHUDA DAVID, Principal Investigator, Medical Corps, Israel Defense Force
ClinicalTrials.gov Identifier: NCT03197545     History of Changes
Other Study ID Numbers: 1579-2015
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be published after statistical analysis only.

Additional relevant MeSH terms:
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Fractures, Bone
Osteoporosis
Fractures, Stress
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases