Bone DiseasesNCT00150163
Odense Androgen Study: Study of Androgens, Body Composition, and Muscle Function in Danish Men
An observational study of Bone Diseases, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Objective: To define a reference-population of healthy young men (20-29 years old). To establish reference-intervals for: 1. Total, bioavailable and free serum androgens (testosterone, dihydrotestosterone, androstenedione) and serum estrogens (estradiol, estrone). 2. Total and free IGF-1. Read more about this study
- Who is it for?
- Ages 20 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Diseases
- How many people
- 800 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2002to Dec 2008
- 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 20 to 29 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 20-29 years
- Residence: County of Funen, Denmark
Who cannot join
- Opioid drug addiction
- Cancer
- Severe chronic disease
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Endocrinology, Odense University Hospital
Odense, Funen, 5000
About this study
Official title: Odense Androgen Study - A Population-Based Study of Androgens, Body Composition, and Muscle Function in 20-29 Year-Old Danish Men
Objective:
- To define a reference-population of healthy young men (20-29 years old).
- To establish reference-intervals for:
Read more
- Total, bioavailable and free serum androgens (testosterone, dihydrotestosterone, androstenedione) and serum estrogens (estradiol, estrone).
- Total and free IGF-1.
- To study the influence of physical activity, alcohol intake, tobacco and abuse of anabolic steroids on serum levels of androgens.
- To identify the androgens (or estrogens) that primarily reflect the following parameters:
- Muscle mass, muscle strength, muscle power, oxygen uptake, and hematocrit.
- Bone mineral density and bone metabolism.
- Total and visceral fat mass.
- Lipid- and glucose metabolism and glucocorticoid metabolism.
- Sexual function and quality of life.
- To study the modifying effect of birth weight, the AR gene CAG-repeat polymorphism, and the level of IGF-1 on associations between serum androgens and the measures above:
Ethics, design and schedule:
The local ethic review board approved a population-based, cross-sectional study planned for the inclusion of 800 Caucasian men, 20 to 29 year old, living in the County of Funen. The only exclusion criteria were opioid drug addiction, cancer, and severe chronic disease. A basic questionnaire was mailed to 3000 men, randomly drawn from the Danish Central Personal Registry. Adequately answered questionnaires were returned from 2,199 men, who subsequently received an invitation to participate. Informed consent was obtained from 783 men. The examinations started in March 2002 and terminated in May 2003. Within subject variation was determined for all study parameters in 20 men. The men included matched the men answering the questionnaire on all questionnaire items and demographics. All analyses have been performed, except for the additional serum sex hormone assays, IGF-1 assays and AR gene analyses.
A sequential rule-out from the reference population was performed on the following criteria:
- testicular pathology: bilateral cryptorchidism, varicocele, testes volumina < 10 ml (each), history of spermatic cord torsion.
- severe chronic disease.
- regular medication or abuse of anabolic steroids.
- body mass index < 19 kg/m2.
- safety serum parameters: luteinizing hormone (LH) <1.0 U/L or >8.4 U/l, alanine-amino-transferase (ALAT) >70 U/l and thyrotropin (TSH) >6.0 mU/l.
- Conditions
- Bone Diseases
- Keywords
- Androgens, Bone, Muscle, Estrogens, Fat, Lipid and glucose metabolism
- Medical subject headings
- Bone Diseases, Platelet Glycoprotein IV Deficiency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startMar 2002
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Prospective
- Enrolment
- 800 participants
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Torben L. Nielsen, MD, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00150163
- Sponsor's protocol ID
- 015
- Status last verified
- Sep 2005
- First submitted
- 6 Sep 2005
- Last updated
- 29 Mar 2007
- Results posted
- No
Publications
Nielsen TL, Wraae K, Brixen K, Hermann AP, Andersen M, Hagen C. Prevalence of overweight, obesity and physical inactivity in 20- to 29-year-old, Danish men. Relation to sociodemography, physical dysfunction and low socioeconomic status: the Odense Androgen Study. Int J Obes (Lond). 2006 May;30(5):805-15. doi: 10.1038/sj.ijo.0803197.
PubMed 16418764Frost M, Abrahamsen B, Nielsen TL, Hagen C, Andersen M, Brixen K. Vitamin D status and PTH in young men: a cross-sectional study on associations with bone mineral density, body composition and glucose metabolism. Clin Endocrinol (Oxf). 2010 Nov;73(5):573-80. doi: 10.1111/j.1365-2265.2010.03847.x.
PubMed 20718769
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Odense Androgen Study - A Population-Based Study of Androgens, Body Composition, and Muscle Function in 20-29 Year-Old Danish Men
- ClinicalTrials.gov ID
- NCT00150163
- Acronym / sponsor ID
- 015
- Conditions
- Bone Diseases
- Keywords
- Androgens, Bone, Muscle, Estrogens, Fat, Lipid and glucose metabolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Mar 2002
- Study completion
- Dec 2008
- First posted
- 8 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.
Objective:
- To define a reference-population of healthy young men (20-29 years old).
- To establish reference-intervals for:
- Total, bioavailable and free serum androgens (testosterone, dihydrotestosterone, androstenedione) and serum estrogens (estradiol, estrone).
- Total and free IGF-1.
- To study the influence of physical activity, alcohol intake, tobacco and abuse of anabolic steroids on serum levels of androgens.
- To identify the androgens (or estrogens) that primarily reflect the following parameters:
- Muscle mass, muscle strength, muscle power, oxygen uptake, and hematocrit.
- Bone mineral density and bone metabolism.
- Total and visceral fat mass.
- Lipid- and glucose metabolism and glucocorticoid metabolism.
- Sexual function and quality of life.
- To study the modifying effect of birth weight, the AR gene CAG-repeat polymorphism, and the level of IGF-1 on associations between serum androgens and the measures above:
Ethics, design and schedule:
The local ethic review board approved a population-based, cross-sectional study planned for the inclusion of 800 Caucasian men, 20 to 29 year old, living in the County of Funen. The only exclusion criteria were opioid drug addiction, cancer, and severe chronic disease. A basic questionnaire was mailed to 3000 men, randomly drawn from the Danish Central Personal Registry. Adequately answered questionnaires were returned from 2,199 men, who subsequently received an invitation to participate. Informed consent was obtained from 783 men. The examinations started in March 2002 and terminated in May 2003. Within subject variation was determined for all study parameters in 20 men. The men included matched the men answering the questionnaire on all questionnaire items and demographics. All analyses have been performed, except for the additional serum sex hormone assays, IGF-1 assays and AR gene analyses.
A sequential rule-out from the reference population was performed on the following criteria:
- testicular pathology: bilateral cryptorchidism, varicocele, testes volumina < 10 ml (each), history of spermatic cord torsion.
- severe chronic disease.
- regular medication or abuse of anabolic steroids.
- body mass index < 19 kg/m2.
- safety serum parameters: luteinizing hormone (LH) <1.0 U/L or >8.4 U/l, alanine-amino-transferase (ALAT) >70 U/l and thyrotropin (TSH) >6.0 mU/l.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age: 20-29 years
- Residence: County of Funen, Denmark
Key exclusion criteria (3 listed)
- Opioid drug addiction
- Cancer
- Severe chronic disease
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 29 Mar 2007.
- Results publication: PubMed 16418764Nielsen TL, Wraae K, Brixen K, Hermann AP, Andersen M, Hagen C. Prevalence of overweight, obesity and physical inactivity in 20- to 29-year-old, Danish men. Relation to sociodemography, physical dysfunction and low socioeconomic status: the Odense Androgen Study. Int J Obes (Lond). 2006 May;30(5):805-15. doi: 10.1038/sj.ijo.0803197.
- Derived from this study: PubMed 20718769Frost M, Abrahamsen B, Nielsen TL, Hagen C, Andersen M, Brixen K. Vitamin D status and PTH in young men: a cross-sectional study on associations with bone mineral density, body composition and glucose metabolism. Clin Endocrinol (Oxf). 2010 Nov;73(5):573-80. doi: 10.1111/j.1365-2265.2010.03847.x.
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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.
Torben L. Nielsen, MD 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 Bone Diseases, 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 2 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: status not confirmed, as of the sponsor's last update on 29 Mar 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?
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 NCT00150163, which also lists 2 linked publications.
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 29 Mar 2007.