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CompletedNCT03400982COURDO2Updated Sep 25, 2023

Reference Curve on Bone Mineral Density in Men

An interventional study of Bone densitometry measurement in Bone Mineral Density, Grip Strength and Physical Performance, sponsored by Centre Hospitalier Régional d'Orléans. Completed at 3 sites in France. Open to male participants aged 20 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-25.

Sponsored by Centre Hospitalier Régional d'Orléans · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
20 Years to 30 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Bone Mineral Density
  • Grip Strength
  • Physical Performance
03

Who can participate

Ages eligible
20 Years to 30 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male
  • Aged between 20 and 30 years
  • Caucasians

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    Bone Mineral Density

    Bone densitometry measurement: measurement of bone mineral densitometry with bone densitometry

    Diagnostic Test: Bone densitometry measurement

Interventions

  • Diagnostic testBone densitometry measurement

    Bone densitometry and measurement of body composition

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: Day 0

  2. 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

    Time frame: Day 0

Secondary outcomes

  1. Fat mass of the body

    to establish reference curves in elderly mal volunteers from 20 to 30 years through the assessment of body composition

    Time frame: day 0

  2. Lean mass of the body

    to establish reference curves in elderly mal volunteers from 20 to 30 years through the assessment of body composition

    Time frame: day 0

06

Study locations

3 sites
  • CHU Amiens
    Amiens, 80054, France
  • Hopital Lariboisiere
    Paris, 75010, France
  • CHU de Saint Etienne
    Saint-Étienne, 42055, France
07

References and documents

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 9286764 ↗
  • 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. PubMed 9425200 ↗
  • 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. PubMed 8234779 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03400982
Lead sponsor
Centre Hospitalier Régional d'Orléans
Responsible party
Sponsor
First posted
Jan 17, 2018
Start date
Jan 23, 2020
Primary completion
Aug 18, 2023
Completion
Aug 18, 2023
Last update
Sep 25, 2023

Study contacts

Eric LESPESSAILLES
principal investigator · CHR Orléans

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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