Reference Curve on Bone Mineral Density in Young Adult: French Multicenter Study (COURDO)

In men, the hope of lower life, the absence of equivalent of menopause and the existence of a higher peak bone mass are three factors that explain the lower incidence of osteoporosis in men. Epidemiological data indicate a prevalence of 15% among men aged over 50 years (Szulc et al. 2000). According to global analyzes, the number of fractures of the upper end of the femur in humans will increase from 400 000 to 800 000 per year between 2000 and 2025 (Kanis et al. 2004). Furthermore the mortality due to major osteoporotic fractures when they occur in humans than that seen in women (Johnell and al.2001).The main goal of this study is to establish reference curves in elderly male volunteers from 20 to 30 years through the assessment of bone mineral density of the spine, hip, and the measurement of body composition (fat mass, lean mass). This study will allow us to establish the mean and standard deviation of the value of the young adults of the same sex, which will eventually be applied in the calculation of the "T-score" for older people.

Study Overview

• Status: Completed
• Conditions: Bone Mineral Density; Grip Strength; Physical Performance
• Intervention / Treatment: Diagnostic test: Bone densitometry measurement

• Study Type: Interventional
• Enrollment (Actual): 151
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France, 45000
    • CHRU Lille
  • Lyon, France, 69437
    • CHRU Lyon
  • Orléans, France, 45000
    • CHR Orléans

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Male
• Aged between 20 and 30 years
• Caucasians

Exclusion Criteria:

• Lack of informed consent
• Pieces of metal or plastic parts in the field
• Diseases which cause technical difficulties for the correct evaluation of the hip and spine (severe dysplasia, hip surgery or lumbar spine)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bone mineral density; Bone densitometry measurement : Measurement of bone mineral densitometry with bone densitometry	Diagnostic test: Bone densitometry measurement; 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	to establish reference curves in elderly male volunteers from 20 to 30 years through the assessment of bone mineral density of the spine, hip, the measurement of body composition (fat mass, lean mass)	Day 0
bone mineral density of the hip	to establish reference curves in elderly male volunteers from 20 to 30 years through the assessment of bone mineral density of the spine, hip, the measurement of body composition (fat mass, lean mass)	Day 0
body composition (fat mass, lean mass)	to establish reference curves in elderly male volunteers from 20 to 30 years through the assessment of bone mineral density of the spine, hip, the measurement of body composition (fat mass, lean mass)	day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional d'Orléans
• Investigators: Principal Investigator: Eric LESPESSAILLES, Dr, CHR Orléans

Publications and helpful links

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.
• 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.
• Ahmed AI, Blake GM, Rymer JM, Fogelman I. Screening for osteopenia and osteoporosis: do the accepted normal ranges lead to overdiagnosis? Osteoporos Int. 1997;7(5):432-8. doi: 10.1007/s001980050029.

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2016
• Primary Completion (Actual): March 25, 2018
• Study Completion (Actual): March 25, 2018

Study Registration Dates

• First Submitted: September 22, 2017
• First Submitted That Met QC Criteria: October 17, 2017
• First Posted (Actual): October 20, 2017

Study Record Updates

• Last Update Posted (Actual): May 3, 2018
• Last Update Submitted That Met QC Criteria: May 2, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CHRO-2016-06

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