OsteoporosisNCT00463411
Study of Male Osteoporosis and Aging
An observational study of Osteoporosis, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The aim of this study is to identify potential risk factors for fragility fractures in men. Read more about this study
- Who is it for?
- Ages 60 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- How many people
- 30,000 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2006to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men aged 60-70 being able to consent in writing
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Endocrinology
Odense, 5000
Morten F Nielsen, MD, 0045 22877448 ext. 65413536, frostnielsen@yahoo.com
Kim T Brisen, MD, Ph.d., 0045 65413536, KBR33.OUHADM-POST@ouh.fyns-amt.dk
About this study
Official title: Study on Male Osteoporosis and Aging
The aim of this study is to identify potential risk factors for fragility fractures in men.
Read the 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.
- Conditions
- Osteoporosis
- Keywords
- osteoporosis, male, fracture risk, genetical epidemiology
- Medical subject headings
- Osteoporosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2007 (estimated)
- Study startDec 2006
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Natural history
- Time perspective
- Prospective
- Enrolment
- 30,000 participants
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S, AP Moeller Foundation
- Investigators
- Kim T Brixen, MD. Ph.d, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00463411
- Sponsor's protocol ID
- 025
- Status last verified
- Dec 2006
- First submitted
- 18 Apr 2007
- Last updated
- 20 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Male Osteoporosis and Aging
- ClinicalTrials.gov ID
- NCT00463411
- Acronym / sponsor ID
- 025
- Conditions
- Osteoporosis
- Keywords
- osteoporosis, male, fracture risk, genetical epidemiology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30,000 participants
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S, AP Moeller Foundation
- Study start
- Dec 2006
- Study completion
- Dec 2017 (estimated)
- First posted
- 20 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to identify potential risk factors for fragility fractures in men.
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 design
- Observational model
- Natural history
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men aged 60-70 being able to consent in writing
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim T Brixen, MD. Ph.d principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kim T Brixen, MD, Ph.d (0045 65413536, KBR33.OUHADM-POST@ouh.fyns-amt.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2007.