Stress FractureNCT03197545
Determining the Risk of Stress Fracture in IDF Soldiers Based on SNPs Identified for Osteoporosis
An observational study of Stress Fracture, run by Medical Corps, Israel Defense Force at 1 site in Israel.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Fracture
- How many people
- 440 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2017to Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: 440 male infantry recruits training in an IDF (the Israel Defense Forces) boot camp in Israel
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Arnon Gam, MD contact
Israel1 site, 1 recruiting
- Recruiting
Bar Ilan University
Safed
Yehuda David, 97235097773, yehuda13@gmail.com
About this study
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.
- Conditions
- Stress Fracture
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study startJun 2017 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Corps, Israel Defense Force
- Sponsor type
- University, hospital or other
- Collaborators
- Bar-Ilan University, Israel
- Responsible party
- Principal investigator, YEHUDA DAVID, Medical Corps, Israel Defense Force
- Investigators
- Izhak Haviv, Prof., Study chair, Bar-Ilan Faculty of Medicine, SafedDavid Karasik, Prof., Study director, Bar-Ilan Faculty of Medicine, Safed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03197545
- Sponsor's protocol ID
- 1579-2015
- Status last verified
- Jun 2017
- First submitted
- 19 Jun 2017
- Last updated
- 23 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data will be published after statistical analysis only.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Risk of Stress Fracture in IDF Soldiers Based on SNPs Identified for Osteoporosis
- ClinicalTrials.gov ID
- NCT03197545
- Acronym / sponsor ID
- 1579-2015
- Conditions
- Stress Fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Medical Corps, Israel Defense ForceUniversity, hospital or other
- Collaborators
- Bar-Ilan University, Israel
- Study start
- Jun 2017 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 23 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 440 male infantry recruits training in an IDF (the Israel Defense Forces) boot camp in Israel
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2017.
- Individual participant dataSharing planned: No. Data will be published after statistical analysis only.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnon Gam, MD contact
Izhak Haviv, Prof. study chair
Bar-Ilan Faculty of Medicine, Safed
David Karasik, Prof. study director
Bar-Ilan Faculty of Medicine, Safed
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Fracture, run by Medical Corps, Israel Defense Force at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yehuda David (97235097773, yehuda13@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2017.