NCT02544399

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2009

Typical duration for all trials

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

November 1, 2009

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2015

Completed
Last Updated

September 9, 2015

Status Verified

September 1, 2015

Enrollment Period

3.6 years

First QC Date

September 7, 2015

Last Update Submit

September 8, 2015

Conditions

Keywords

Bone microarchitecturePlaying golfWalkers

Outcome Measures

Primary Outcomes (1)

  • Bone volume / tissue volume

    Measure of Bone volume / tissue volume by the 3D CT scan

    day 1

Study Arms (3)

Subject practicing golf and accept bone measure

Each patient will have 1 blood sample and 1 measure of bone by 3D micro-tomography

Other: 3D CT scan

Subject practicing foot walk and accept bone measure

Each patient will have 1 blood sample and 1 measure of bone by 3D micro-tomography

Other: 3D CT scan

Subject sedentary and accept bone measure

Each patient will have 1 blood sample and 1 measure of bone by 3D micro-tomography

Other: 3D CT scan

Interventions

Measure of bone micro-architecture by 3D micro-tomography

Subject practicing foot walk and accept bone measureSubject practicing golf and accept bone measureSubject sedentary and accept bone measure

Eligibility Criteria

Age60 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subject practicing foot walk or golf or sedentary

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample

Study Officials

  • Thierry THOMAS, MD-PhD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2015

First Posted

September 9, 2015

Study Start

November 1, 2009

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

September 9, 2015

Record last verified: 2015-09