- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02544399
Bone Microarchitecture in Women Practicing Golf
September 8, 2015 updated by: Centre Hospitalier Universitaire de Saint Etienne
Is Golf a Sport Suited to the Female Skeleton After 60 Years? Pilot Study Evaluating the Microarchitecture 3D Carriers and Noncarriers Bones
After the age of 50, one in three women and one in eight men will experience at least one fragility fracture during the rest of their lives.
It is currently recognized that physical activity has an osteogenic actions, especially when it includes the impact transmitted to the skeleton.
In this context, the investigators propose a study to determine whether the regular practice of golf could be particularly beneficial for the skeleton, not only in the lower limbs, due to repeated impacts to the ground when it requires sustained walking, but also the upper limbs due to the impacts transmitted by the club at the time of striking the ball, as has been amply demonstrated with racquet sports.
Study Overview
Detailed Description
Each patient will have 1 blood samples and 1 measure of bone by 3D micro-tomography (3D CT Scan).These examinations and sampling will take place on 1 day.
Study Type
Observational
Enrollment (Actual)
67
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Subject practicing foot walk or golf or sedentary
Description
Inclusion Criteria:
- Golfers: Regular playing golf for over 2 years at 8 to 12 hours per week recruited into golf clubs.
- Walkers: regular practice of walking for over 2 years at 8 to 12 hours per week recruited into the walking clubs.
- Sedentary: no intensive physical activity (<2 hours / week), recruited in clubs seniors.
Exclusion Criteria:
- concomitant bone disease ,
- Hip prosthesis the dominant side
- Endocrinopathy
- hypercalcemia, vitamin D deficiency, hypo- or hyper calciuria
- Active smoking (more than 5 cigarettes / day), chronic alcoholism,
- Treatments received in the previous six months and resounding on bone metabolism such growth promoters, all osteoporosis, corticosteroids.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Subject practicing golf and accept bone measure
Each patient will have 1 blood sample and 1 measure of bone by 3D micro-tomography
|
Measure of bone micro-architecture by 3D micro-tomography
|
|
Subject practicing foot walk and accept bone measure
Each patient will have 1 blood sample and 1 measure of bone by 3D micro-tomography
|
Measure of bone micro-architecture by 3D micro-tomography
|
|
Subject sedentary and accept bone measure
Each patient will have 1 blood sample and 1 measure of bone by 3D micro-tomography
|
Measure of bone micro-architecture by 3D micro-tomography
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bone volume / tissue volume
Time Frame: day 1
|
Measure of Bone volume / tissue volume by the 3D CT scan
|
day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Thierry THOMAS, MD-PhD, CHU Saint-Etienne
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
September 7, 2015
First Submitted That Met QC Criteria
September 8, 2015
First Posted (Estimate)
September 9, 2015
Study Record Updates
Last Update Posted (Estimate)
September 9, 2015
Last Update Submitted That Met QC Criteria
September 8, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 0801092
- 2008-A01265-50 (Other Identifier: AFSSAPS)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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