CClinicalTrials.gg
Status unknownNCT03197545Updated Jun 23, 2017

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

An observational study in Stress Fracture, sponsored by Medical Corps, Israel Defense Force. Status unknown at 1 site in Israel. Open to male participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-23.

Sponsored by Medical Corps, Israel Defense Force · Observational

The sponsor has not verified this record recently (last verified Jun 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
440
Ages
18 Years to 25 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's planned enrollment of 440 is above the median of 174 across 446 observational studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Medical Corps, Israel Defense Force is the lead sponsor of 33 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
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

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

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.
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
440 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

06

What researchers measure

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

    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.

07

Study locations

1 of 1 sites recruiting
  • Bar Ilan University
    Safed, Israel
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — Data will be published after statistical analysis only.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03197545
Lead sponsor
Medical Corps, Israel Defense Force
Collaborators
Bar-Ilan University, Israel
Responsible party
YEHUDA DAVID (Principal Investigator, Medical Corps, Israel Defense Force) — Principal investigator
First posted
Jun 23, 2017
Start date
Jun 2017 (estimated)
Primary completion
Jan 2019 (estimated)
Completion
Jul 2020 (estimated)
Last update
Jun 23, 2017

Study contacts

Yehuda David
Contact
yehuda13@gmail.com
97235097773
Arnon Gam, MD
Contact
dr.gam@hotmail.com
Izhak Haviv, Prof.
study chair · Bar-Ilan Faculty of Medicine, Safed
David Karasik, Prof.
study director · Bar-Ilan Faculty of Medicine, Safed

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion