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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

United States1 site
  • University of Utah

    Salt Lake City, Utah, 84108

Other trials in United States

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

  1. explore differences in volumetric bone mineral density (vBMD), bone geometry, and muscle cross sectional area (MCSA) using pQCT
  2. 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.

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.

  1. First posted3 Oct 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionFeb 2009
  4. Study completionFeb 2009

Resources

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)
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

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.

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