The Genetic and Life Style Determinants of Bone Mass of Young Greek Males

March 18, 2007 updated by: University of Athens

The genetic bases of peak bone mass in males, as determinants of an individual's risk of developing osteoporotic fractures in old age and their interaction with dietary and lifestyle factors are still poorly understood.

Our objective was to examine the relative contribution of genetic and environmental variables to the regulation of peak bone mass in a population-based cohort of young healthy men, focusing on the BsmI polymorphism of vitamin D receptor (VDR)gene and the AluI polymorphism of calcitonin receptor (CTR)gene.

Study Overview

Status

Completed

Conditions

Detailed Description

Material and Methods

Subjects

In this cross-sectional study, 301 Greek healthy young men, aged 16-35 were selected during gradational examinations for the Greek Armed forces. Men who were treated with corticosteroids, anticonvulsants, or anticoagulants or who suffered from hypogonadism, kidney, liver, thyroid and gastrointestinal disease or diabetes mellitus were excluded from the study.

Approval by the hospital ethics committee and informed consent were obtained. Height and body weight were measured with the subjects in sportswear, standing barefoot on a fixed stadiometer and on a standard clinical balance. Height was recorded in centimetres and weight in kilograms. The stadiometer and scale were routinely monitored for accuracy and precision. Body mass index (BMI) was calculated as weight/height 2 .

Dietary Evaluation

Current dietary factors (calcium, proteins, alcohol, coffee and tea intake), were assessed using a food frequency questionnaire validated in the MEDOS study, and completed with an interview. Calcium intake was estimated considering milk, yogurt and cheese consumption. Protein intake was estimated by taking into account the consumption of meat and fish per week. Tea and coffee consumption was also taken into account.

Nondieter factors were investigated using a questionnaire

Physical was quantified as hours of sports activities per week (defined as taking part in organized sport for at least 12 months). Smoking behaviour was coded as 'yes' (daily smoking) or 'no', and sunlight exposure when there was exposure in places abroad during the previous 3 months. Duration of immobilizations was also coded as 'less' or 'more than 1 month' (in majority, due to fractures caused by high energy trauma).

Genetic analyses

Genomic DNA was extracted from peripheral blood leukocytes with a DNA extraction kit (Puregene DNA isolation kit, Gentra Systems Inc., Munich, Germany). Polymorphisms in the CTR and VDR genes were determined by polymerase chain reaction (PCR) as previously described using Taq DNA polymerase (Takara, Tokyo, Japan), and thermal cycler (PCR Primus 96 plus-MWG AG BIOTECH). 4μl of CTR-PCR product were digested with AluI (New England Biolabs, UK) and 2 μl of VDR-PCR product were digested with BsmI (New England Biolabs, UK) according to manufacturer’s instructions. AluI restriction digest yielded DNA fragments of 120/108-bp (TT), 228/120/108-bp (TC) and 228-bp (CC) and BsmI restriction digest yielded DNA fragments of 1200/650-bp (bb), 1850/1200/650-bp (Bb) and 1850-bp (BB), which were visualized using a 3% and 1% agarose gel respectively stained with ethidium bromide.

BMD Measurements

Distal BMC (dBMC), distal BMD (dBMD) and ultradistal BMD (udBMD) at the radius were measured by single X-ray absorptiometry (Osteometer DTX-100, Denmark). Additionally, there were assessments of the corresponding geometrical areas, such as radial area (RadAr), ulnar area (UlnAr) and ultradistal area (udAr). BMD is expressed as grams/cm2; BMC is expressed in grams and Area as cm2 The in vivo precision for the BMD and BMC measurements in our laboratory was 1-5%.

Statistical Analysis

Descriptive statistics were determined for all variables. All variables are sufficiently represented using the mean value (mean) and standard deviation (SD).

Univariate analysis was performed using the two-sample Student's test or Welch-test (in a case of unequal SDs) and the model of one-way analysis of variance with no repeated measurements (pairwise multiple comparisons were analysed using the Tukey test). Analysis of covariance (ANCOVA) used the bone values (BMC, BMD, Area) as dependent variables, the VDR and CTR polymorphisms as factors and age, weight and height as covariates. Furthermore, multiple stepwise regression analysis was used to determine significant predictors of BMD. All tests are two sided; P<0, 05 was defined as significant. All data analysis was performed using the Statistical Package for Social Sciences (version 10.0) software (SPSS Inc., Chicago, IL).

Study Type

Observational

Enrollment

301

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 14561
        • Laboratory for Research of Musculoskeletal System, University of Athens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 35 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Greek healthy young men

Exclusion Criteria:

  • Men who were treated with corticosteroids, anticonvulsants, or anticoagulants or who suffered from hypogonadism, kidney, liver, thyroid and gastrointestinal disease or diabetes mellitus were excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Athens

Investigators

  • Principal Investigator: Ioannis N Charopoulos, M.D, Laboratory Of Research Of Musculoskeletal System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Study Completion (ACTUAL)

December 1, 2006

Study Registration Dates

First Submitted

March 18, 2007

First Submitted That Met QC Criteria

March 18, 2007

First Posted (ESTIMATE)

March 20, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

March 20, 2007

Last Update Submitted That Met QC Criteria

March 18, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AA-88-H-0010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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