Study of Male Osteoporosis and Aging

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2006 by Odense University Hospital
Sponsor:
Collaborators:
Novo Nordisk A/S
AP Moeller Foundation
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00463411
First received: April 18, 2007
Last updated: April 19, 2007
Last verified: December 2006
  Purpose

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


Condition
Osteoporosis

Study Type: Observational
Study Design: Allocation: Random Sample
Observational Model: Natural History
Time Perspective: Longitudinal
Official Title: Study on Male Osteoporosis and Aging

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Estimated Enrollment: 30000
Study Start Date: December 2006
Estimated Study Completion Date: December 2017
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.

  Eligibility

Ages Eligible for Study:   60 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men aged 60-70 being able to consent in writing
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00463411     History of Changes
Other Study ID Numbers: 025
Study First Received: April 18, 2007
Last Updated: April 19, 2007
Health Authority: Denmark: National Board of Health

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

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

ClinicalTrials.gov processed this record on September 30, 2014