- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03400982
Reference Curve on Bone Mineral Density in Men (COURDO2)
September 22, 2023 updated by: Centre Hospitalier Régional d'Orléans
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 Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Aurélie Despujols
- Phone Number: 33 2 38 74 40 71
- Email: aurelie.despujols@chr-orleans.fr
Study Contact Backup
- Name: Elodie TATSI TOTOUOM
- Phone Number: 33 2 38 74 40 86
- Email: elodie.tatsi-totouom@chr-orleans.fr
Study Locations
-
-
-
Amiens, France, 80054
- CHU Amiens
-
Paris, France, 75010
- Hopital Lariboisiere
-
Saint-Étienne, France, 42055
- CHU de Saint Etienne
-
-
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
20 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Male
- Aged between 20 and 30 years
- Caucasians
Exclusion Criteria:
- 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
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
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bone Mineral Density
Bone densitometry measurement: measurement of bone mineral densitometry with bone densitometry
|
Bone densitometry and measurement of body composition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Day 0
|
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
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fat mass of the body
Time Frame: day 0
|
to establish reference curves in elderly mal volunteers from 20 to 30 years through the assessment of body composition
|
day 0
|
Lean mass of the body
Time Frame: day 0
|
to establish reference curves in elderly mal volunteers from 20 to 30 years through the assessment of body composition
|
day 0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Eric LESPESSAILLES, CHR Orléans
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Smotherman 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.
- Baumgartner RN. Body composition in elderly persons: a critical review of needs and methods. Prog Food Nutr Sci. 1993 Jul-Sep;17(3):223-60.
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 (Actual)
January 23, 2020
Primary Completion (Actual)
August 18, 2023
Study Completion (Actual)
August 18, 2023
Study Registration Dates
First Submitted
December 7, 2017
First Submitted That Met QC Criteria
January 15, 2018
First Posted (Actual)
January 17, 2018
Study Record Updates
Last Update Posted (Actual)
September 25, 2023
Last Update Submitted That Met QC Criteria
September 22, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- CHRO-2017-10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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