NCT03316625

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2017

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 20, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2018

Completed
Last Updated

May 3, 2018

Status Verified

October 1, 2017

Enrollment Period

2 years

First QC Date

September 22, 2017

Last Update Submit

May 2, 2018

Conditions

Bone Mineral DensityGrip StrengthPhysical Performance

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

Bone mineral density

EXPERIMENTAL

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

Diagnostic Test: Bone densitometry measurement

Interventions

Bone densitometry measurementDIAGNOSTIC_TEST

Bone Densitometry and measurement of body composition

Bone mineral density

Eligibility Criteria

Age20 Years - 30 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • Aged between 20 and 30 years
  • Caucasians

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Chru Lille

Lille, 45000, France

Location

CHRU Lyon

Lyon, 69437, France

Location

CHR Orléans

Orléans, 45000, France

Location

Related Publications (3)

  • 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.

    PMID: 9286764BACKGROUND

  • 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.

    PMID: 9425500BACKGROUND

  • 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.

    PMID: 8234779BACKGROUND

Study Officials

  • Eric LESPESSAILLES, Dr

    CHR Orléans

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2017

First Posted

October 20, 2017

Study Start

March 25, 2016

Primary Completion

March 25, 2018

Study Completion

March 25, 2018

Last Updated

May 3, 2018

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)