Viewing Study NCT00037414



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Study NCT ID: NCT00037414
Status: COMPLETED
Last Update Posted: 2023-09-13
First Post: 2002-05-16

Brief Title: Joint Determinants of Bone Density and CVD Calcification
Sponsor: University of Maryland Baltimore
Organization: University of Maryland Baltimore

Study Overview

Official Title: None
Status: COMPLETED
Status Verified Date: 2023-09
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: To evaluate the relationship bone marrow density and coronary artery and aortic calcification
Detailed Description: BACKGROUND

There is growing evidence of a link between osteoporosis and atherosclerosis Recent studies document that bone mineral density BMD is inversely correlated with severity of aortic and coronary artery calcification markers of atherosclerosis Cardiovascular disease and osteoporosis have tremendous negative public health impacts on the nation Besides increased mortality these negative impacts include severely diminished quality of life and huge financial burdens With an ever aging population this situation will get even worse As increasing numbers of individuals now live well into their 80s and 90s there is a great deal of interest on what has become known as healthy aging

The study is in response to a Request for Applications RFA entitled Bone Formation and Calcification in Cardiovascular Disease which was developed jointly with the National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS to support research into the pathophysiology and molecular mechanisms of vascular calcification and the possible links between vascular calcification bone formation and cardiovascular disease The RFA was released in January 2001

DESIGN NARRATIVE

The study evaluates the relationship between BMD and coronary artery and aortic calcification measured by electron beam computed tomography in 700 members of a large Amish pedigree already participating in the Amish Family Osteoporosis Study AFOS By focusing on families the investigators hope to tease out the respective contributions of genetic and non-genetic factors to this clustering of traits The AFOS was initiated in 1997 to identify genes influencing susceptibility to osteoporosis in families ascertained for fracture risk Through NIH funding available to the AFOS parent study the investigators will genotype 391 highly polymorphic short tandem repeat STR markers spaced at approximately 10 cM intervals and perform a genome-wide scan to detect quantitative trait loci QTLs associated with variation in bone marrow density and related traits The Old Order Amish are ideal for the studies since they are a closed founder population who are relatively genetically homogeneous have very large family sizes and well-documented genealogies The study uses the available measures of bone marrow density related traits and genotypes in the AFOS along with the newly collected measures of vascular calcification

The specific goals are to determine if bone marrow density is correlated with coronary artery and aortic calcification CAC and if so to determine the contribution of common genes or shared environments to this association in families The investigators will next assess genetic heritability and non-genetic contributions to variability in vascular calcification determinants of CAC in these families They will assess the individual and joint contributions of lipid oxidation to bone marrow density and vascular calcification Using the extensive genotyping that will be available they will perform a genome wide scan of coronary artery and aortic calcification These results will complement the similar analyses obtained on the bone-related phenotypes Finally they will determine if chromosomal regions linked to variation in bone marrow density are also linked to variation in vascular calcification or to another possible joint determinant such as CAC or to lipid oxidation

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01HL069313 NIH None httpsreporternihgovquickSearchR01HL069313