Bone MicroarchitectureNCT02544399
Bone Microarchitecture in Women Practicing Golf
An observational study of Bone Microarchitecture, run by Centre Hospitalier Universitaire de Saint Etienne.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Microarchitecture
- What is being tested?
- 3D CT scan
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Jun 2013
- 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 60 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subject practicing foot walk or golf or sedentary
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Bone Microarchitecture
- Being tested
- 3D CT scan
- Keywords
- Bone microarchitecture, Playing golf, Walkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D CT scanOther
Measure of bone micro-architecture by 3D micro-tomography
| Study group | Role | What they receive |
|---|---|---|
| Subject practicing golf and accept bone measure | Each patient will have 1 blood sample and 1 measure of bone by 3D micro-tomography Receives: 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 Receives: 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 Receives: Other: 3D CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone volume / tissue volume
Measure of Bone volume / tissue volume by the 3D CT scan
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startNov 2009
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone MicroarchitectureStudies 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
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry THOMAS, MD-PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544399
- Sponsor's protocol ID
- 0801092
- Other IDs
- 2008-A01265-50
- Status last verified
- Sep 2015
- First submitted
- 7 Sep 2015
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Golf a Sport Suited to the Female Skeleton After 60 Years? Pilot Study Evaluating the Microarchitecture 3D Carriers and Noncarriers Bones
- ClinicalTrials.gov ID
- NCT02544399
- Acronym / sponsor ID
- 0801092
- Conditions
- Bone Microarchitecture
- Keywords
- Bone microarchitecture, Playing golf, Walkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 9 Sep 2015 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subject practicing golf and accept bone measure | – | Other: 3D CT scanEach patient will have 1 blood sample and 1 measure of bone by 3D micro-tomography |
| Subject practicing foot walk and accept bone measure | – | Other: 3D CT scanEach patient will have 1 blood sample and 1 measure of bone by 3D micro-tomography |
| Subject sedentary and accept bone measure | – | Other: 3D CT scanEach patient will have 1 blood sample and 1 measure of bone by 3D micro-tomography |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subject practicing foot walk or golf or sedentary
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D CT scanMeasure of bone micro-architecture by 3D micro-tomography | Other | Subject practicing foot walk and accept bone measure, Subject practicing golf and accept bone measure, Subject sedentary and accept bone measure |
Primary outcome
Bone volume / tissue volume
Time frame: day 1
Measure of Bone volume / tissue volume by the 3D CT scan
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 9 Sep 2015.
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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.
Thierry THOMAS, MD-PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Microarchitecture, run by Centre Hospitalier Universitaire de Saint Etienne.
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 3 inclusion and 6 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 9 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Bone volume / tissue volume (time frame: day 1). It is what the study was designed to measure, not a finding.
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 9 Sep 2015.