Bone DiseasesNCT00155961
Odense Androgen Study in the Elderly
An observational study of Bone Diseases and Metabolic Syndrome, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Introduction Male ageing is associated with sarcopenia, frailty, osteopenia, obesity, the metabolic syndrome and cardiovascular disease. To what extent the androgens affect these signs of ageing is still largely undetermined. Read more about this study
- Who is it for?
- Ages 60 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Diseases, Metabolic Syndrome
- How many people
- 600 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2002to not given
- 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 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 60-75 years
Who cannot join
- Cancer
- Severe chronic disease
- Opioid drug addiction
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Endocrinology, Odense University Hospital
Odense, Funen, 5000
About this study
Introduction
Male ageing is associated with sarcopenia, frailty, osteopenia, obesity, the metabolic syndrome and cardiovascular disease. To what extent the androgens affect these signs of ageing is still largely undetermined. A few studies have shown divergent results concerning the relation between ageing and serum levels of testosterone. It still remains to be shown whether there is a pure age-related decline in serum testosterone or whether other factors such as obesity, chronic illness or medication are responsible for the lower serum testosterone found in elderly men when compared with young men. To investigate these issues a cohort of 600 men aged 60 to 75 years is examined.
Read more
Objective
The aim of the study is to investigate the relation of testosterone (T) to body composition (BC) and physical performance (PP). Measures for BC are muscle mass (MM), bone mineral density (BMD) and fat mass (FM). Parameters for PP are maximum voluntary force (MVF), maximum oxygen uptake (VO2max) and muscle power (P). We hypothesize that T is positively associated with MM, BMD and all PP parameters, but negatively associated with FM. We will furthermore examine whether life style, medication, chronic disease, hormones and binding proteins exert their actions on BC and PP solely through or independently of T. The levels of s-total and free T in this cohort will be compared with the s-total and free T levels from a cohort of young men aged 20 to 30 years. Furthermore the associations found between T and BC and PP in the two cohorts will be compared to investigate whether T plays the same role in the two groups.
Read the detailed description
Introduction
Male ageing is associated with sarcopenia, frailty, osteopenia, obesity, the metabolic syndrome and cardiovascular disease. To what extent the androgens affect these signs of ageing is still largely undetermined. A few studies have shown divergent results concerning the relation between ageing and serum levels of testosterone. It still remains to be shown whether there is a pure age-related decline in serum testosterone or whether other factors such as obesity, chronic illness or medication are responsible for the lower serum testosterone found in elderly men when compared with young men. To investigate these issues a cohort of 600 men aged 60 to 75 years is examined.
Objective
The aim of the study is to investigate the relation of testosterone (T) to body composition (BC) and physical performance (PP). Measures for BC are muscle mass (MM), bone mineral density (BMD) and fat mass (FM). Parameters for PP are maximum voluntary force (MVF), maximum oxygen uptake (VO2max) and muscle power (P). We hypothesize that T is positively associated with MM, BMD and all PP parameters, but negatively associated with FM. We will furthermore examine whether life style, medication, chronic disease, hormones and binding proteins exert their actions on BC and PP solely through or independently of T. The levels of s-total and free T in this cohort will be compared with the s-total and free T levels from a cohort of young men aged 20 to 30 years. Furthermore the associations found between T and BC and PP in the two cohorts will be compared to investigate whether T plays the same role in the two groups.
Methods
All blood analyses are determined in fasting condition from venous samples drawn between 8 and 9 a.m. The influence of life style, medication, chronic disease, hormones and binding proteins on T, BC and PP are assessed by four questionnaires, a physical examination and blood tests. MM is determined regionally (truncal, lower and upper extremities) and as total by Dual Energy X-ray Absorptiometry (DEXA), and specifically by MRI with cross sectional area of femoral and axial muscles. MVF of m. biceps brachii and m. triceps surae is measured isometrically. P is measured with the Nottingham Powerrig. VO2max is determined on a Monark ergometer bike using a Jaeger Oxycon Pro. BMD is determined specifically (femoral and lumbar) as well as total bone mass is estimated by DEXA. The ratio of intraperitoneal area/volume of fat to total abdominal area/volume is determined by MRI, and likewise is also abdominal subcutaneous FM. Finally BMI and waist-to-hip ratio are measured.
Results
Initially a questionnaire providing us with basic demographic, social, occupational and other information about men from Funen aged 60 to 75 was randomly mailed to 4,964 men. Of these questionnaires, 89% were returned and 85.2% of the returned questionnaires had been completed. Afterwards 1,650 people received an invitation by mail to get an introduction to the project via telephone. Of these 1,650 people 50.8% accepted to be contacted. So far 762 people have been contacted in a randomly manner and of these people, 74% have agreed to participate in the project. In the beginning of April 2005, 550 people have been included in Odense Androgen Study in the Elderly.
- Conditions
- Bone Diseases, Metabolic Syndrome
- Keywords
- Androgens, Metabolic syndrome, Bone mineral density, Body composition, Questionnaire
- Medical subject headings
- Bone Diseases, Metabolic Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startMar 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone DiseasesStudies 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
- Time perspective
- Other
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Claus Hagen, MD, DMSc, Principal investigator, Gentofte County Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00155961
- Sponsor's protocol ID
- 016
- Status last verified
- Sep 2005
- First submitted
- 6 Sep 2005
- Last updated
- 3 Feb 2006
- Results posted
- No
Publications
Glintborg D, Nielsen TL, Wraae K, Hougaard D, Gudex C, Brixen K, Andersen M. The relationship between health-related quality of life, obesity and testosterone levels in older men. Age Ageing. 2014 Mar;43(2):280-4. doi: 10.1093/ageing/aft203. Epub 2013 Dec 29.
PubMed 24375324
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Odense Androgen Study in the Elderly
- ClinicalTrials.gov ID
- NCT00155961
- Acronym / sponsor ID
- 016
- Conditions
- Bone Diseases, Metabolic Syndrome
- Keywords
- Androgens, Metabolic syndrome, Bone mineral density, Body composition, Questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Mar 2002
- First posted
- 12 Sep 2005 (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.
Introduction
Male ageing is associated with sarcopenia, frailty, osteopenia, obesity, the metabolic syndrome and cardiovascular disease. To what extent the androgens affect these signs of ageing is still largely undetermined. A few studies have shown divergent results concerning the relation between ageing and serum levels of testosterone. It still remains to be shown whether there is a pure age-related decline in serum testosterone or whether other factors such as obesity, chronic illness or medication are responsible for the lower serum testosterone found in elderly men when compared with young men. To investigate these issues a cohort of 600 men aged 60 to 75 years is examined.
Objective
The aim of the study is to investigate the relation of testosterone (T) to body composition (BC) and physical performance (PP). Measures for BC are muscle mass (MM), bone mineral density (BMD) and fat mass (FM). Parameters for PP are maximum voluntary force (MVF), maximum oxygen uptake (VO2max) and muscle power (P). We hypothesize that T is positively associated with MM, BMD and all PP parameters, but negatively associated with FM. We will furthermore examine whether life style, medication, chronic disease, hormones and binding proteins exert their actions on BC and PP solely through or independently of T. The levels of s-total and free T in this cohort will be compared with the s-total and free T levels from a cohort of young men aged 20 to 30 years. Furthermore the associations found between T and BC and PP in the two cohorts will be compared to investigate whether T plays the same role in the two groups.
Detailed description
Introduction
Male ageing is associated with sarcopenia, frailty, osteopenia, obesity, the metabolic syndrome and cardiovascular disease. To what extent the androgens affect these signs of ageing is still largely undetermined. A few studies have shown divergent results concerning the relation between ageing and serum levels of testosterone. It still remains to be shown whether there is a pure age-related decline in serum testosterone or whether other factors such as obesity, chronic illness or medication are responsible for the lower serum testosterone found in elderly men when compared with young men. To investigate these issues a cohort of 600 men aged 60 to 75 years is examined.
Objective
The aim of the study is to investigate the relation of testosterone (T) to body composition (BC) and physical performance (PP). Measures for BC are muscle mass (MM), bone mineral density (BMD) and fat mass (FM). Parameters for PP are maximum voluntary force (MVF), maximum oxygen uptake (VO2max) and muscle power (P). We hypothesize that T is positively associated with MM, BMD and all PP parameters, but negatively associated with FM. We will furthermore examine whether life style, medication, chronic disease, hormones and binding proteins exert their actions on BC and PP solely through or independently of T. The levels of s-total and free T in this cohort will be compared with the s-total and free T levels from a cohort of young men aged 20 to 30 years. Furthermore the associations found between T and BC and PP in the two cohorts will be compared to investigate whether T plays the same role in the two groups.
Methods
All blood analyses are determined in fasting condition from venous samples drawn between 8 and 9 a.m. The influence of life style, medication, chronic disease, hormones and binding proteins on T, BC and PP are assessed by four questionnaires, a physical examination and blood tests. MM is determined regionally (truncal, lower and upper extremities) and as total by Dual Energy X-ray Absorptiometry (DEXA), and specifically by MRI with cross sectional area of femoral and axial muscles. MVF of m. biceps brachii and m. triceps surae is measured isometrically. P is measured with the Nottingham Powerrig. VO2max is determined on a Monark ergometer bike using a Jaeger Oxycon Pro. BMD is determined specifically (femoral and lumbar) as well as total bone mass is estimated by DEXA. The ratio of intraperitoneal area/volume of fat to total abdominal area/volume is determined by MRI, and likewise is also abdominal subcutaneous FM. Finally BMI and waist-to-hip ratio are measured.
Results
Initially a questionnaire providing us with basic demographic, social, occupational and other information about men from Funen aged 60 to 75 was randomly mailed to 4,964 men. Of these questionnaires, 89% were returned and 85.2% of the returned questionnaires had been completed. Afterwards 1,650 people received an invitation by mail to get an introduction to the project via telephone. Of these 1,650 people 50.8% accepted to be contacted. So far 762 people have been contacted in a randomly manner and of these people, 74% have agreed to participate in the project. In the beginning of April 2005, 550 people have been included in Odense Androgen Study in the Elderly.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age: 60-75 years
Key exclusion criteria (3 listed)
- Cancer
- Severe chronic disease
- Opioid drug addiction
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2006.
- Derived from this study: PubMed 24375324Glintborg D, Nielsen TL, Wraae K, Hougaard D, Gudex C, Brixen K, Andersen M. The relationship between health-related quality of life, obesity and testosterone levels in older men. Age Ageing. 2014 Mar;43(2):280-4. doi: 10.1093/ageing/aft203. Epub 2013 Dec 29.
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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.
Claus Hagen, MD, DMSc principal investigator
Gentofte County 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 Bone Diseases and Metabolic Syndrome, 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 3 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: finished, as of the sponsor's last update on 3 Feb 2006. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00155961, which also lists 1 linked publication.
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 3 Feb 2006.