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

Not Applicable

Completed

• Conditions: Physical Performance; Bone Mineral Density; Grip Strength
• Interventions: Diagnostic Test: Bone densitometry measurement

• Registration Number: NCT03316625
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-25
• Study First Submitted: 2017-09-22
• Status Verified: 2017-10
• Study First Submitted QC: 2017-10-17
• Study First Posted: 2017-10-20
• Primary Completion: 2018-03-25
• Study Completion: 2018-03-25
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 151

Inclusion Criteria

• Male
• Aged between 20 and 30 years
• Caucasians

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bone mineral density	Bone densitometry measurement	Bone densitometry measurement : Measurement of bone mineral densitometry with bone densitometry

Primary Outcome Measures

Name	Time	Method
body composition (fat mass, lean mass)	day 0	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)
bone mineral density of the spine	Day 0	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)
bone mineral density of the hip	Day 0	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)

Trial Locations

Locations (3)

Chru Lille; 🇫🇷 Lille, France

CHRU Lyon; 🇫🇷 Lyon, France

CHR Orléans; 🇫🇷 Orléans, France