Viewing Study NCT01382966



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Last Modification Date: 2024-10-26 @ 10:37 AM
Study NCT ID: NCT01382966
Status: UNKNOWN
Last Update Posted: 2011-06-28
First Post: 2011-06-21

Brief Title: Serum Sclerostin Levels Cardiovascular Parameters and Carpal Tunnel Syndrome in Maintenance Hemodialysis Patients
Sponsor: RFM Renal Treatment Services
Organization: RFM Renal Treatment Services

Study Overview

Official Title: The Association of Serum Sclerostin LevelsEchocardiographic Parameters Arteriovenous Fistula Thrombosis and Carpal Tunnel Syndrome in Maintenance Hemodialysis Patients
Status: UNKNOWN
Status Verified Date: 2011-06
Last Known Status: NOT_YET_RECRUITING
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: Sclerostin the product of the SOST gene located on chromosome 17 locus q112 in humans was originally believed to be a non-classical Bone morphogenetic protein BMP antagonistSclerostin was recently identified as a component of parathyroid hormone PTH signal transduction

Chronic kidney disease CKD is associated with abnormalities in bone and mineral metabolismNew advances in the pathogenesis of renal osteodystrophy ROD change the perspective from which many of its features and treatment are viewed Calcium phosphate parathyroid hormone PTH and vitamin D have been shown to be important determinants of survival associated with kidney diseases Now ROD dependent and independent of these factors is linked to survival more than just skeletal frailtyFurthermore ROD is shown to be an underappreciated factor in the level of the serum phosphorus in CKD The discovery and the elucidation of the mechanism of hyperphosphatemia as a cardiovascular risk in CKD change the view of ROD

Emerging current data suggests a promising role for serum measurements of sclerostin in addition to iPTH in the diagnosis of high bone turnover in chronic kidney disease-5D patients dialysis patients

Because of the close relationship between ROD and cardiovascular disease the aim of this study is to investigate the association between sclerostin arteriovenous fistula thrombosis echocardiography and carpal tunnel syndrome in maintenance hemodialysis patients
Detailed Description: Sclerostin the product of the SOST gene located on chromosome 17 locus q112 in humans was originally believed to be a non-classical Bone morphogenetic protein BMP antagonistMore recently Sclerostin has been identified as binding to LRP56 receptors and inhibiting the Wnt signalling pathway Wnt activation under these circumstances is antagonistic to bone formation Although the underlying mechanisms are unclear it is believed that the antagonism of BMP-induced bone formation by sclerostin is mediated by Wnt signalling but not BMP signalling pathways

Sclerostin is produced by the osteocyte and has catabolic effects on bone formation This protein with a length of 113 residues has a dssp secondary structure that is 28 beta sheet 6 strands 32 residues Sclerostin has an inhibitory effect on the lifetime of the osteoblast Sclerostin production by osteocytes is inhibited by parathyroid hormone mechanical loading and cytokines including oncostatin M cardiotrophin-1 and leukemia inhibitory factor Sclerostin production is increased by calcitonin Thus osteoblast activity is self regulated by a negative feedback systemSclerostin was recently identified as a component of parathyroid hormone PTH signal transduction

Chronic kidney disease CKD is associated with abnormalities in bone and mineral metabolismRenal osteodystrophy ROD is one of the three components of chronic kidney disease-mineral and bone disorder CKD-MBD Patients with CKD may develop various types of bone disease spanning the spectrum of extreme situations such as severe osteitis fibrosa osteomalacia mixed osteopathy and adynamic bone disease In addition patients may have osteoporosis which increases the risk for fractures both in advanced and in less severe CKD stages 2- 4which in turn result in excess mortality New advances in the pathogenesis of renal osteodystrophy ROD change the perspective from which many of its features and treatment are viewed Calcium phosphate parathyroid hormone PTH and vitamin D have been shown to be important determinants of survival associated with kidney diseases Now ROD dependent and independent of these factors is linked to survival more than just skeletal frailtyFurthermore ROD is shown to be an underappreciated factor in the level of the serum phosphorus in CKD The discovery and the elucidation of the mechanism of hyperphosphatemia as a cardiovascular risk in CKD change the view of ROD Emerging current data suggests a promising role for serum measurements of sclerostin in addition to iPTH in the diagnosis of high bone turnover in chronic kidney disease-5D patients dialysis patients

The demonstration that the level of serum sclerostinwhich is directly produced by osteocytes is a good predictor for bone formation in patients with CKD may be of clinical interestBecause of the close relationship between ROD and cardiovascular disease the aim of this study is to investigate the association between sclerostin arteriovenous fistula thrombosis echocardiography and carpal tunnel syndrome in maintenance hemodialysis patients

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