Study of Male Osteoporosis and Aging

NCT ID: NCT00463411

Last Updated: 2007-04-20

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

UNKNOWN

Total Enrollment

30000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-12-31

Study Completion Date

2017-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Osteoporosis

Study Design

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Observational Model Type

NATURAL_HISTORY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Men aged 60-70 being able to consent in writing
Minimum Eligible Age

60 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role collaborator

AP Moeller Foundation

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Kim T Brixen, MD. Ph.d

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Locations

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Department of Endocrinology

Odense, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Kim T Brixen, MD, Ph.d

Role: CONTACT

0045 65413536

Morten F Nielsen, MD

Role: CONTACT

0045 22877448

Facility Contacts

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Morten F Nielsen, MD

Role: primary

0045 22877448 ext. 65413536

Kim T Brisen, MD, Ph.d.

Role: backup

0045 65413536

Other Identifiers

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025

Identifier Type: -

Identifier Source: org_study_id