Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00011323
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2001-02-15
Brief Title:
Determining the Risk Factors Such as Smoking Alcohol and Caffeine and Their Association With Osteoporosis in Men
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Prevalence and Determinants of Osteoporosis in Male Veterans
Status:
COMPLETED
Status Verified Date:
2003-02
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 goals of this project are to establish a new cohort of male veterans and describe associations between potential risk factors and baseline bone mineral density BMD as well as rates of BMD loss
Detailed Description:
Primary Hypothesis Risk factors such as smoking alcohol and caffeine are associated with osteoporosis in men
Intervention None
Primary Outcomes Percent reduction in cross-sectional bone mineral density over time
Study Abstract The goals of this project are to establish a new cohort of male veterans and describe associations between potential risk factors and baseline bone mineral density BMD as well as rates of BMD loss
The study is a two-year observational prospective study of 1000 male veterans aged 50 and older The subjects are drawn from two existing VA cohorts the Normative Aging Study NAS and the Veterans Health Study VHS Examinations to be performed on each subject baseline and two follow-up exams include BMD measurement at the hip forearm and total body anthropometry hand grip strength and questionnaires on current diet physical activity tobacco alcohol use sunlight exposure health related quality of life Medical Outcomes Study Short Form depression Brief Depression Scale fracture history medications and psychological factors PrimeMD MiniMental Additional data on historical exposure to risk factors previously obtained in the NAS or VHS studies will also be correlated with BMD and BMD loss Multivariate linear and logistic models with control for potential confounders will be used in the main analyses Examinations take place at the Boston VA Outpatient Clinic
Examinations on each subject include BMD measurement at the hip forearm and total body height and weight hand grip strength leg extensor strength and mobility Questionnaires on current diet physical activity tobacco alcohol use sunlight exposure health related quality of life Medical Outcomes Study Short Form depression Brief Depression Scale fracture history medications and psychological factors PrimeMD MiniMental are administered Each subject also contributes a nonfasting blood sample and a 24-hour urine sample
Beginning in April 1999 two additional measures are being obtained as a result of a 4-year supplemental VA Epidemiology grant awarded to Dr Miller These are the heel ultrasound measure and a 4-day physical activity level determined by ambulatory monitor
Preliminary cross-sectional analysis of mean BMD for femoral neck total body and forearm BMD suggest the percent reduction in cross-sectional BMD between ages 60-69 and 80-89 is approximately 9 per decade at the femoral neck 5decade at the total body and 8decade at the forearm These age-related patterns agree well with other studies of BMD in older men
The x-ray densitometer was installed at the Boston VA Outpatient Clinic in April 1998 and the study technician was certified for bone density measurements during the three-day training session that followed A precision study was conducted in the following month In vivo reproducibility was determined by performing 5 repeat scans of each of the three sites on 5 volunteers ranging in age from 21 to 50 years Subjects were repositioned between each scan The coefficient of variation CV of femoral neck BMD in our laboratory is 092 for whole body BMD 072 and for distal radius BMD 104 An aluminum spine phantom with known density 1254 gmcm2 is scanned every two weeks on the DPX-IQ The mean standard deviation of 15 measurements is 1250 00058 coefficient of variation 046 There has been no detectable drift in phantom values during the study start-up phase
When completed this study will be one of the largest in the US to study risk factors for osteoporosis in men historically an understudied group in relation to osteoporosis Several of the hypothesized risk factors smoking alcohol caffeine for example are amenable to change and represent potential areas of intervention Thus not only can the VA make a valuable contribution to furthering our understanding of osteoporosis in men in general but strategies may be identified to reduce morbidity as well as reduce health care costs associated with fracture in the elderly
Intervention None
Primary Outcomes Percent reduction in cross-sectional bone mineral density over time
Study Abstract The goals of this project are to establish a new cohort of male veterans and describe associations between potential risk factors and baseline bone mineral density BMD as well as rates of BMD loss
The study is a two-year observational prospective study of 1000 male veterans aged 50 and older The subjects are drawn from two existing VA cohorts the Normative Aging Study NAS and the Veterans Health Study VHS Examinations to be performed on each subject baseline and two follow-up exams include BMD measurement at the hip forearm and total body anthropometry hand grip strength and questionnaires on current diet physical activity tobacco alcohol use sunlight exposure health related quality of life Medical Outcomes Study Short Form depression Brief Depression Scale fracture history medications and psychological factors PrimeMD MiniMental Additional data on historical exposure to risk factors previously obtained in the NAS or VHS studies will also be correlated with BMD and BMD loss Multivariate linear and logistic models with control for potential confounders will be used in the main analyses Examinations take place at the Boston VA Outpatient Clinic
Examinations on each subject include BMD measurement at the hip forearm and total body height and weight hand grip strength leg extensor strength and mobility Questionnaires on current diet physical activity tobacco alcohol use sunlight exposure health related quality of life Medical Outcomes Study Short Form depression Brief Depression Scale fracture history medications and psychological factors PrimeMD MiniMental are administered Each subject also contributes a nonfasting blood sample and a 24-hour urine sample
Beginning in April 1999 two additional measures are being obtained as a result of a 4-year supplemental VA Epidemiology grant awarded to Dr Miller These are the heel ultrasound measure and a 4-day physical activity level determined by ambulatory monitor
Preliminary cross-sectional analysis of mean BMD for femoral neck total body and forearm BMD suggest the percent reduction in cross-sectional BMD between ages 60-69 and 80-89 is approximately 9 per decade at the femoral neck 5decade at the total body and 8decade at the forearm These age-related patterns agree well with other studies of BMD in older men
The x-ray densitometer was installed at the Boston VA Outpatient Clinic in April 1998 and the study technician was certified for bone density measurements during the three-day training session that followed A precision study was conducted in the following month In vivo reproducibility was determined by performing 5 repeat scans of each of the three sites on 5 volunteers ranging in age from 21 to 50 years Subjects were repositioned between each scan The coefficient of variation CV of femoral neck BMD in our laboratory is 092 for whole body BMD 072 and for distal radius BMD 104 An aluminum spine phantom with known density 1254 gmcm2 is scanned every two weeks on the DPX-IQ The mean standard deviation of 15 measurements is 1250 00058 coefficient of variation 046 There has been no detectable drift in phantom values during the study start-up phase
When completed this study will be one of the largest in the US to study risk factors for osteoporosis in men historically an understudied group in relation to osteoporosis Several of the hypothesized risk factors smoking alcohol caffeine for example are amenable to change and represent potential areas of intervention Thus not only can the VA make a valuable contribution to furthering our understanding of osteoporosis in men in general but strategies may be identified to reduce morbidity as well as reduce health care costs associated with fracture in the elderly
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: