AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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

Other trials in Denmark

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.

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.

  1. First posted12 Sep 2005 (estimated)
  2. Study startMar 2002

Resources

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
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in