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NCT00463411 Clinical Trial

Study of Male Osteoporosis and Aging

Osteoporosis Clinical Trial

Official title:
Study on Male Osteoporosis and Aging

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00463411
Other study ID # 025
Secondary ID
Status Recruiting
Phase N/A
First received April 18, 2007
Last updated April 19, 2007
Start date December 2006
Est. completion date December 2017

Study information
Verified date December 2006
Source Odense University Hospital
Contact Kim T Brixen, MD, Ph.d
Phone 0045 65413536
Email KBR33.OUHADM-POST@ouh.fyns-amt.dk
Is FDA regulated No
Health authority Denmark: National Board of Health
Study type Observational

Clinical Trial Summary

The aim of this study is to identify potential risk factors for fragility fractures in men.

Description:

Osteoporosis is a disease characterized by decreased bone mass and pathological changes in the microarchitecture of the bones. The clinical significance of osteoporosis is the association with fragility fractures and, consequently, increases in both morbidity and mortality.

In men, genetical and life-style factors are known to affect the risk of fractures, however, data relating these factors with measures of bone mineral density and fracture risk are limited.

30.000 men aged 60-70 were randomly selected from the Central Office of Civil Registration in Denmark. Each receive a questionnaire addressing demographics, potential risk factors of osteoporosis, past medical history and medication by mail. In case of consent, the participants will complete a full medical examination including DXA and sampling of DNA if they have a fragility fracture. At the same time, 2 participants from the study population will be selected as control. The study period is 10 years.

Recruitment information / eligibility
Status Recruiting
Enrollment 30000
Est. completion date December 2017
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 60 Years to 70 Years
Eligibility Inclusion Criteria:

- Men aged 60-70 being able to consent in writing

Study Design

Allocation: Random Sample, Observational Model: Natural History, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Department of Endocrinology Odense

Sponsors (3)
Lead Sponsor Collaborator
Odense University Hospital AP Moeller Foundation, Novo Nordisk A/S

Country where clinical trial is conducted

Denmark, 

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