NCT00766077

Brief 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. 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

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 3, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

April 14, 2010

Status Verified

April 1, 2010

Enrollment Period

5 months

First QC Date

October 2, 2008

Last Update Submit

April 12, 2010

Conditions

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Fractures, Stress

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Study Officials

  • Laurie J Mileur, PhD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 2, 2008

First Posted

October 3, 2008

Study Start

September 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

April 14, 2010

Record last verified: 2010-04

Locations