Stress FracturesNCT00766077
Bone Geometry, Strength, and Biomechanical Changes in Runners With a History of Stress Fractures
An observational study of Stress Fractures and Bone Geometry, run by University of Utah at 1 site in United States.
Trial summary
Stress fractures are a common and debilitating injury for a variety of athletes however current evidence does not clearly allow easy prediction of athletes at risk for a first fracture. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Fractures, Bone Geometry, Bone Strength
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Feb 2009
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants must be competitive female distance runners between the ages of 18-35. Athletes must currently be healthy, have been training for a minimum of 5 years and running 25 or more miles per week during their competitive season.
Who may be able to join
- Participants must be competitive female distance runners between the ages of 18-35.
- Athletes must currently be healthy, have been training for a minimum of 5 years and running 25 or more miles per week during their competitive season.
Who cannot join
- Participants will be excluded if they currently have a known chronic health problem, currently have a stress fracture or lower limb injury, currently have or have had an eating disorder, are on medication known to influence bone density and/or bone metabolism, or are pregnant. A pregnancy test will be administered to all female participants prior to any pQCT or DXA scans.
Trial locations and contacts
1 site in 1 country.
About this study
Stress fractures are a common and debilitating injury for a variety of athletes however current evidence does not clearly allow easy prediction of athletes at risk for a first fracture. Animal and some preliminary human evidence suggest that assessment of bone strength, muscle size and running mechanics may be primary risk factors for stress fractures. The investigators study will help determine which, if any, of these modifiable risk factors could help identify athletes at risk for stress fracture.
Competitive female distance runners will be recruited for this study. Participants will placed into a stress fracture or control group based on stress fracture history. Dual energy x-ray absorptiometry (DXA) and peripheral Quantitative Computed Tomography (pQCT) will be used to assess bone structure and strength. Running mechanics will be assessed during a 30-40 minute fatiguing run. A treadmill with an embedded force plate and high speed video will be used to assess changes in running mechanics throughout the run.
Read more
The purpose of this project will be to
- explore differences in volumetric bone mineral density (vBMD), bone geometry, and muscle cross sectional area (MCSA) using pQCT
- explore changes in load (GRFs) and running mechanics that occur during a fatiguing run in runners with and without a history of stress fracture.
Read the detailed description
Stress fractures are among the most prevalent sports injuries, particularly in sports involving running, jumping, and repetitive cyclic loading. Stress fractures have been diagnosed in as many as 20% of athletes. The highest prevalence of stress fractures among athletes is reported in members of track and field teams with rates from 10-31% (22). Stress fractures are also a common occurrence in military basic training. U.S. military reports from the recruit populations indicate an incidence rate of 0.2 to 4% in men, and 1 to 7% in women (1).
Due to the prevalence of stress fractures in the military and athletic population, as well as the costly nature of the injury in terms of recovery time, it is important to understand the causative factors and the means by which these factors relate and interact (25, 29) . The most commonly studied and measured risk factors for stress fractures are surrogates of bone strength-particularly bone mineral density. Although several previous studies have explored the relationship of areal bone mineral density (aBMD, g/cm2) to stress fractures, the findings remain controversial (6, 7, 9, 12, 17, 28). A majority of these studies have used dual energy x-ray absorptiometry (DXA) and aBMD as the assessment of bone strength. DXA is limited in its 2-dimensional assessment of a 3-dimensional bone and is also unable to distinguish between different types of bone(13, 30). Given the limitations of DXA imaging, measuring bone properties using peripheral Quantitative Computed Tomography (pQCT) may shed light on inconsistencies found in the current literature. Peripheral QCT is a 3-dimensional imaging technique that allows for measurement of both trabecular and cortical volumetric bone density, bone geometry (total area, cortical area), and estimates of bone mechanical strength (i.e. cross-sectional moment of inertia and section modulus) which better represent a bones mechanical competence (26, 31).
With any fracture, a bone will fail only if the load on the bone is higher than the strength of that bone. In the case of stress fractures, it has been suggested that those at risk for stress fracture may alter biomechanics with fatigue such that strain on bone is increased with fatigue causing an increase in microdamage and ultimate fracture. Research measuring kinetic and kinematic variables has shown changes in GRFs (10, 11, 16, 19, 21), strain magnitude, strain rate, strain distributions (8, 14, 15, 24), and landing strategies after the onset of muscle fatigue in healthy individuals. It has also been shown that when muscles are fatigued, their ability to absorb impact forces during landing, their internal timing ability between functioning muscle groups, and ability to counter bending moments is decreased (2-5, 18, 20, 23). It has been hypothesized that runners who are ineffective at altering movement kinematics experience greater increases in loading rates and impact magnitudes, making them more susceptible to injury than runners who are able to make appropriate alterations (16). However, the majority of these studies have been conducted during resting conditions and in athletes with no history of injury. No previous studies to our knowledge have adequately characterized the change in biomechanics during a fatiguing run in athletes with and without a history of stress fracture.
- Conditions
- Stress Fractures, Bone Geometry, Bone Strength, Biomechanical Changes
- Medical subject headings
- Fractures, Stress
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress FracturesStudies 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
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Investigators
- Laurie J Mileur, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00766077
- Sponsor's protocol ID
- 29496
- Status last verified
- Apr 2010
- First submitted
- 2 Oct 2008
- Last updated
- 14 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Geometry, Strength, and Biomechanical Changes in Runners With a History of Stress Fractures
- ClinicalTrials.gov ID
- NCT00766077
- Acronym / sponsor ID
- 29496
- Conditions
- Stress Fractures, Bone Geometry, Bone Strength, Biomechanical Changes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 3 Oct 2008 (estimated)
- 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.
Stress fractures are a common and debilitating injury for a variety of athletes however current evidence does not clearly allow easy prediction of athletes at risk for a first fracture. Animal and some preliminary human evidence suggest that assessment of bone strength, muscle size and running mechanics may be primary risk factors for stress fractures. The investigators study will help determine which, if any, of these modifiable risk factors could help identify athletes at risk for stress fracture.
Competitive female distance runners will be recruited for this study. Participants will placed into a stress fracture or control group based on stress fracture history. Dual energy x-ray absorptiometry (DXA) and peripheral Quantitative Computed Tomography (pQCT) will be used to assess bone structure and strength. Running mechanics will be assessed during a 30-40 minute fatiguing run. A treadmill with an embedded force plate and high speed video will be used to assess changes in running mechanics throughout the run.
The purpose of this project will be to
- explore differences in volumetric bone mineral density (vBMD), bone geometry, and muscle cross sectional area (MCSA) using pQCT
- explore changes in load (GRFs) and running mechanics that occur during a fatiguing run in runners with and without a history of stress fracture.
Detailed description
Stress fractures are among the most prevalent sports injuries, particularly in sports involving running, jumping, and repetitive cyclic loading. Stress fractures have been diagnosed in as many as 20% of athletes. The highest prevalence of stress fractures among athletes is reported in members of track and field teams with rates from 10-31% (22). Stress fractures are also a common occurrence in military basic training. U.S. military reports from the recruit populations indicate an incidence rate of 0.2 to 4% in men, and 1 to 7% in women (1).
Due to the prevalence of stress fractures in the military and athletic population, as well as the costly nature of the injury in terms of recovery time, it is important to understand the causative factors and the means by which these factors relate and interact (25, 29) . The most commonly studied and measured risk factors for stress fractures are surrogates of bone strength-particularly bone mineral density. Although several previous studies have explored the relationship of areal bone mineral density (aBMD, g/cm2) to stress fractures, the findings remain controversial (6, 7, 9, 12, 17, 28). A majority of these studies have used dual energy x-ray absorptiometry (DXA) and aBMD as the assessment of bone strength. DXA is limited in its 2-dimensional assessment of a 3-dimensional bone and is also unable to distinguish between different types of bone(13, 30). Given the limitations of DXA imaging, measuring bone properties using peripheral Quantitative Computed Tomography (pQCT) may shed light on inconsistencies found in the current literature. Peripheral QCT is a 3-dimensional imaging technique that allows for measurement of both trabecular and cortical volumetric bone density, bone geometry (total area, cortical area), and estimates of bone mechanical strength (i.e. cross-sectional moment of inertia and section modulus) which better represent a bones mechanical competence (26, 31).
With any fracture, a bone will fail only if the load on the bone is higher than the strength of that bone. In the case of stress fractures, it has been suggested that those at risk for stress fracture may alter biomechanics with fatigue such that strain on bone is increased with fatigue causing an increase in microdamage and ultimate fracture. Research measuring kinetic and kinematic variables has shown changes in GRFs (10, 11, 16, 19, 21), strain magnitude, strain rate, strain distributions (8, 14, 15, 24), and landing strategies after the onset of muscle fatigue in healthy individuals. It has also been shown that when muscles are fatigued, their ability to absorb impact forces during landing, their internal timing ability between functioning muscle groups, and ability to counter bending moments is decreased (2-5, 18, 20, 23). It has been hypothesized that runners who are ineffective at altering movement kinematics experience greater increases in loading rates and impact magnitudes, making them more susceptible to injury than runners who are able to make appropriate alterations (16). However, the majority of these studies have been conducted during resting conditions and in athletes with no history of injury. No previous studies to our knowledge have adequately characterized the change in biomechanics during a fatiguing run in athletes with and without a history of stress fracture.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants must be competitive female distance runners between the ages of 18-35. Athletes must currently be healthy, have been training for a minimum of 5 years and running 25 or more miles per week during their competitive season.
Key inclusion criteria (2 listed)
- Participants must be competitive female distance runners between the ages of 18-35.
- Athletes must currently be healthy, have been training for a minimum of 5 years and running 25 or more miles per week during their competitive season.
Key exclusion criteria (1 listed)
- Participants will be excluded if they currently have a known chronic health problem, currently have a stress fracture or lower limb injury, currently have or have had an eating disorder, are on medication known to influence bone density and/or bone metabolism, or are pregnant. A pregnancy test will be administered to all female participants prior to any pQCT or DXA scans.
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2010.
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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.
Laurie J Mileur, PhD principal investigator
University of Utah
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 Fractures and Bone Geometry, run by University of Utah at 1 site in United States.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 14 Apr 2010. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 14 Apr 2010; AzTrials last refreshed its copy on 30 Oct 2026.