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

NCT03197545 | Unknown

• 1 other identifier: 1579-2015
• Study Type: observational
• Target: 440
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Fracture

Outcome Measures

Primary Outcomes (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.

  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.

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

440 male infantry recruits training in an IDF (the Israel Defense Forces) boot camp in Israel

You may qualify if:

• All participants (440) in the research are male.
• All participants (440) are recruits who serve 4-6 months in the IDF - infantry - basic training.
• recruits with a stress fracture diagnosis in their medical portfolio.
• recruits who have Section 4161x flaw (section Eclipse: a long bone fracture)
• recruits without the aforementioned impairment clause and the above mentioned diagnosis (referred as control group).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical Corps, Israel Defense Force: lead
• Bar-Ilan University, Israel: collaborator

Study Sites (1)

Bar Ilan University

Safed, Israel

RECRUITING

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).

MeSH Terms

Conditions

Fractures, Stress

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Officials

• Izhak Haviv, Prof.

  Bar-Ilan Faculty of Medicine, Safed

  STUDY CHAIR

• David Karasik, Prof.

  Bar-Ilan Faculty of Medicine, Safed

  STUDY DIRECTOR

Central Study Contacts

Yehuda David

CONTACT

97235097773; yehuda13@gmail.com

Arnon Gam, MD

CONTACT

dr.gam@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 23, 2017
• Study Start: June 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: July 1, 2020
• Last Updated: June 23, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)