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

NCT ID: NCT03316625

Last Updated: 2018-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-25

Study Completion Date

2018-03-25

Brief Summary

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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

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Conditions

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Bone Mineral Density Grip Strength Physical Performance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Bone mineral density

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

Group Type EXPERIMENTAL

Bone densitometry measurement

Intervention Type DIAGNOSTIC_TEST

Bone Densitometry and measurement of body composition

Interventions

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Bone densitometry measurement

Bone Densitometry and measurement of body composition

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Régional d'Orléans

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric LESPESSAILLES, Dr

Role: PRINCIPAL_INVESTIGATOR

CHR Orléans

Locations

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Chru Lille

Lille, , France

Site Status

CHRU Lyon

Lyon, , France

Site Status

CHR Orléans

Orléans, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 9286764 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9425500 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8234779 (View on PubMed)

Other Identifiers

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CHRO-2016-06

Identifier Type: -

Identifier Source: org_study_id

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