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

Physical Performance Clinical Trial

— COURDO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03316625
• Other study ID #: CHRO-2016-06
• Status: Completed
• Phase: N/A
• Start date: March 25, 2016
• Est. completion date: March 25, 2018

Study information

• Verified date: October 2017
• Source: Centre Hospitalier Régional d'Orléans
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: March 25, 2018
• Est. primary completion date: March 25, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 30 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bone Mineral Density
• Grip Strength
• Physical Performance

Intervention

Diagnostic Test:
• Bone densitometry measurement
Bone Densitometry and measurement of body composition

Locations

Country	Name	City	State
France	Chru Lille	Lille
France	CHRU Lyon	Lyon
France	CHR Orléans	Orléans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

References & 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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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