Bone Mineral DensityCOURDO2NCT03400982
Reference Curve on Bone Mineral Density in Men
A study testing Bone densitometry measurement in people with Bone Mineral Density and Grip Strength, run by Centre Hospitalier Régional d'Orléans at 3 sites in France.
Trial summary
In men, the hope of lower life, the absence of equivalent of menopause and the existence of a higher peak bone mass are the three factors that explain the lower incidence of osteoporosis in men. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Mineral Density, Grip Strength, Physical Performance
- What is being tested?
- Bone densitometry measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesFrance
- Study dates
- 23 Jan 2020to 18 Aug 2023
- Phase
- Interventional
- 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 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Aged between 20 and 30 years
- Caucasians
Who cannot join
- Lack of express consent
- Pieces of metal or plastic parts in field
- Diseases which cause technical difficulties for the correct evaluation of the hip and spine (severe dysplasia, hip surgery or lumbar spine)
- Adult protect buy the law
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU Amiens
Amiens, 80054
Hopital Lariboisiere
Paris, 75010
CHU de Saint Etienne
Saint-Etienne, 42055
About this study
In men, the hope of lower life, the absence of equivalent of menopause and the existence of a higher peak bone mass are the three factors that explain the lower incidence of osteoporosis in men.
- Conditions
- Bone Mineral Density, Grip Strength, Physical Performance
- Being tested
- Bone densitometry measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone densitometry measurementDiagnostic test
Bone densitometry and measurement of body composition
| Study group | Role | What they receive |
|---|---|---|
| Bone Mineral Density | Experimental | Bone densitometry measurement: measurement of bone mineral densitometry with bone densitometry Receives: Diagnostic Test: Bone densitometry measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density of the spine
to establish reference curves in elderly mal volunteers from 20 to 30 years through the assessment of bone mineral density of the spine
Measured: Day 0
Bone mineral density of the hip
to establish reference curves in elderly mal volunteers from 20 to 30 years through the assessment of bone mineral density of the hip
Measured: Day 0
Secondary outcomes (2)
Fat mass of the body
to establish reference curves in elderly mal volunteers from 20 to 30 years through the assessment of body composition
Measured: day 0
Lean mass of the body
to establish reference curves in elderly mal volunteers from 20 to 30 years through the assessment of body composition
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start23 Jan 2020
- Primary completion18 Aug 2023
- Study completion18 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bone Mineral DensityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric LESPESSAILLES, Principal investigator, CHR Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400982
- Sponsor's protocol ID
- CHRO-2017-10
- Acronym
- COURDO2
- Status last verified
- Sep 2023
- First submitted
- 7 Dec 2017
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abrahamsen B, Hansen TB, Jensen LB, Hermann AP, Eiken P. Site of osteodensitometry in perimenopausal women: correlation and limits of agreement between anatomic regions. J Bone Miner Res. 1997 Sep;12(9):1471-9. doi: 10.1359/jbmr.1997.12.9.1471.
PubMed 9286764Smotherman MS, Narins PM. Effect of temperature on electrical resonance in leopard frog saccular hair cells. J Neurophysiol. 1998 Jan;79(1):312-21. doi: 10.1152/jn.1998.79.1.312.
PubMed 9425200Baumgartner RN. Body composition in elderly persons: a critical review of needs and methods. Prog Food Nutr Sci. 1993 Jul-Sep;17(3):223-60.
PubMed 8234779
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reference Curve on Bone Mineral Density in Men
- ClinicalTrials.gov ID
- NCT03400982
- Acronym / sponsor ID
- COURDO2 / CHRO-2017-10
- Conditions
- Bone Mineral Density, Grip Strength, Physical Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 18 Aug 2023 (actual)
- Study completion
- 18 Aug 2023 (actual)
- First posted
- 17 Jan 2018 (actual)
- 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.
In men, the hope of lower life, the absence of equivalent of menopause and the existence of a higher peak bone mass are the three factors that explain the lower incidence of osteoporosis in men.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bone Mineral Density | Experimental | Diagnostic Test: Bone densitometry measurementBone densitometry measurement: measurement of bone mineral densitometry with bone densitometry |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male
- Aged between 20 and 30 years
- Caucasians
Key exclusion criteria (4 listed)
- Lack of express consent
- Pieces of metal or plastic parts in field
- Diseases which cause technical difficulties for the correct evaluation of the hip and spine (severe dysplasia, hip surgery or lumbar spine)
- Adult protect buy the law
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 |
|---|---|---|
| Bone densitometry measurementBone densitometry and measurement of body composition | Diagnostic test | Bone Mineral Density |
Primary outcome
Bone mineral density of the spine
Time frame: Day 0
to establish reference curves in elderly mal volunteers from 20 to 30 years through the assessment of bone mineral density of the spine
Bone mineral density of the hip
Time frame: Day 0
to establish reference curves in elderly mal volunteers from 20 to 30 years through the assessment of bone mineral density of the hip
2 secondary outcomes
Fat mass of the body
Time frame: day 0
Lean mass of the body
Time frame: day 0
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 25 Sep 2023.
- Background: PubMed 9286764Abrahamsen B, Hansen TB, Jensen LB, Hermann AP, Eiken P. Site of osteodensitometry in perimenopausal women: correlation and limits of agreement between anatomic regions. J Bone Miner Res. 1997 Sep;12(9):1471-9. doi: 10.1359/jbmr.1997.12.9.1471.
- Background: PubMed 9425200Smotherman MS, Narins PM. Effect of temperature on electrical resonance in leopard frog saccular hair cells. J Neurophysiol. 1998 Jan;79(1):312-21. doi: 10.1152/jn.1998.79.1.312.
- Background: PubMed 8234779Baumgartner RN. Body composition in elderly persons: a critical review of needs and methods. Prog Food Nutr Sci. 1993 Jul-Sep;17(3):223-60.
- Individual participant dataSharing planned: No
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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.
Eric LESPESSAILLES principal investigator
CHR Orléans
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone densitometry measurement in people with Bone Mineral Density and Grip Strength, run by Centre Hospitalier Régional d'Orléans at 3 sites in France.
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 4 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 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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.
What does the primary outcome measure?
Bone mineral density of the spine (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03400982, which also lists 3 linked publications.
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 25 Sep 2023; AzTrials last refreshed its copy on 28 Oct 2026.