Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00449215
Status:
COMPLETED
Last Update Posted:
2007-03-20
First Post:
2007-03-18
Brief Title:
The Genetic and Life Style Determinants of Bone Mass of Young Greek Males
Sponsor:
University of Athens
Organization:
University of Athens
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The genetic bases of peak bone mass in males as determinants of an individuals 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 VDRgene and the AluI polymorphism of calcitonin receptor CTRgene
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 VDRgene and the AluI polymorphism of calcitonin receptor CTRgene
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 weightheight 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 manufacturerâs instructions AluI restriction digest yielded DNA fragments of 120108-bp TT 228120108-bp TC and 228-bp CC and BsmI restriction digest yielded DNA fragments of 1200650-bp bb 18501200650-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 gramscm2 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 Students 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 P0 05 was defined as significant All data analysis was performed using the Statistical Package for Social Sciences version 100 software SPSS Inc Chicago IL
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 weightheight 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 manufacturerâs instructions AluI restriction digest yielded DNA fragments of 120108-bp TT 228120108-bp TC and 228-bp CC and BsmI restriction digest yielded DNA fragments of 1200650-bp bb 18501200650-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 gramscm2 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 Students 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 P0 05 was defined as significant All data analysis was performed using the Statistical Package for Social Sciences version 100 software SPSS Inc Chicago IL
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None