NCT03400982

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 the three factors that explain the lower incidence of osteoporosis in men.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 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

First Submitted

Initial submission to the registry

December 7, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
2 years until next milestone

Study Start

First participant enrolled

January 23, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2023

Completed
Last Updated

September 25, 2023

Status Verified

September 1, 2023

Enrollment Period

3.6 years

First QC Date

December 7, 2017

Last Update Submit

September 22, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    Day 0

  • 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

    Day 0

Secondary Outcomes (2)

  • Fat mass of the body

    day 0

  • Lean mass of the body

    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 and measurement of body composition

Bone Mineral Density

Eligibility Criteria

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

You may qualify if:

  • Male
  • Aged between 20 and 30 years
  • Caucasians

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU Amiens

Amiens, 80054, France

Location

Hopital Lariboisiere

Paris, 75010, France

Location

CHU de Saint Etienne

Saint-Etienne, 42055, 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
  • 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.

    PMID: 9425200BACKGROUND
  • 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

    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

December 7, 2017

First Posted

January 17, 2018

Study Start

January 23, 2020

Primary Completion

August 18, 2023

Study Completion

August 18, 2023

Last Updated

September 25, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations