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Study of Male Osteoporosis and Aging

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ClinicalTrials.gov Identifier: NCT00463411
Recruitment Status : Unknown
Verified December 2006 by Odense University Hospital.
Recruitment status was:  Recruiting
First Posted : April 20, 2007
Last Update Posted : April 20, 2007
Sponsor:
Collaborators:
Novo Nordisk A/S
AP Moeller Foundation
Information provided by:
Odense University Hospital

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

Condition or disease
Osteoporosis

Detailed 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.


Study Type : Observational
Enrollment : 30000 participants
Allocation: Random Sample
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Study on Male Osteoporosis and Aging
Study Start Date : December 2006
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis





Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00463411


Contacts
Contact: Kim T Brixen, MD, Ph.d 0045 65413536 KBR33.OUHADM-POST@ouh.fyns-amt.dk
Contact: Morten F Nielsen, MD 0045 22877448 frostnielsen@yahoo.com

Locations
Denmark
Department of Endocrinology Recruiting
Odense, Denmark, 5000
Contact: Morten F Nielsen, MD    0045 22877448 ext 65413536    frostnielsen@yahoo.com   
Contact: Kim T Brisen, MD, Ph.d.    0045 65413536    KBR33.OUHADM-POST@ouh.fyns-amt.dk   
Sponsors and Collaborators
Odense University Hospital
Novo Nordisk A/S
AP Moeller Foundation
Investigators
Principal Investigator: Kim T Brixen, MD. Ph.d Odense University Hospital

ClinicalTrials.gov Identifier: NCT00463411     History of Changes
Other Study ID Numbers: 025
First Posted: April 20, 2007    Key Record Dates
Last Update Posted: April 20, 2007
Last Verified: December 2006

Keywords provided by Odense University Hospital:
osteoporosis
male
fracture risk
genetical epidemiology

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases