Trial record 18 of 25 for:    Open Studies | "Rickets"

Serum Sclerostin Levels, Cardiovascular Parameters and Carpal Tunnel Syndrome in Maintenance Hemodialysis Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by RFM Renal Treatment Services.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
RFM Renal Treatment Services
ClinicalTrials.gov Identifier:
NCT01382966
First received: June 21, 2011
Last updated: June 27, 2011
Last verified: June 2011
  Purpose

Sclerostin, the product of the SOST gene, located on chromosome 17, locus q11.2 in humans, was originally believed to be a non-classical Bone morphogenetic protein (BMP) antagonist.Sclerostin was recently identified as a component of parathyroid hormone (PTH) signal transduction.

Chronic kidney disease (CKD) is associated with abnormalities in bone and mineral metabolism.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 frailty.Furthermore, 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.


Condition
Chronic Kidney Disease
Renal Osteodystrophy
Left Ventricular Hypertrophy

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: The Association of Serum Sclerostin Levels,Echocardiographic Parameters, Arteriovenous Fistula Thrombosis and Carpal Tunnel Syndrome in Maintenance Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by RFM Renal Treatment Services:

Primary Outcome Measures:
  • Number of Participants with left ventricular hypertrophy or left ventricular dysfunction according to tertiles of the serum sclerostin levels [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of Participants with arteriovenous fistula thrombosis [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Number of Participants with carpal tunnel syndrome according to tertiles of the serum sclerostin levels [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: July 2011
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Single group
Maintenance hemodialysis patients of minimal 6 months of hemodialysis duration; free of malignancy, infection and autoimmune disease; age over 18 years

Detailed Description:

Sclerostin, the product of the SOST gene, located on chromosome 17, locus q11.2 in humans, was originally believed to be a non-classical Bone morphogenetic protein (BMP) antagonist.More recently Sclerostin has been identified as binding to LRP5/6 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 system.Sclerostin was recently identified as a component of parathyroid hormone (PTH) signal transduction.

Chronic kidney disease (CKD) is associated with abnormalities in bone and mineral metabolism.Renal 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- 4),which, 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 frailty.Furthermore, 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 sclerostin,which is directly produced by osteocytes, is a good predictor for bone formation in patients with CKD may be of clinical interest.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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Maintenance hemodialysis patients (minimum 6 months of duration) No infection, malignancy and autoimmune disease Age> 18 years

Criteria

Inclusion Criteria:

  • Maintenance hemodialysis patients (minimum 6 months of duration)
  • Willingness
  • Age > 18 years

Exclusion Criteria:

  • Infection
  • Malignancy
  • Autoimmune disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01382966

Locations
Turkey
Rfm Renal Tedavi Merkezi Not yet recruiting
Ankara, Turkey, 06810
Contact: FAHRİ MANDIROĞLU, MD    +903123176065    fmoglu@hotmail.com   
Principal Investigator: ALPER KIRKPANTUR, MD         
Sub-Investigator: BARIŞ SELOĞLU, MD         
Sub-Investigator: MEHMET ALKIŞ, MD         
Sponsors and Collaborators
RFM Renal Treatment Services
Investigators
Principal Investigator: ALPER KIRKPANTUR, MD RFM Renal Treatment Services
  More Information

Publications:
Responsible Party: RFM RENAL TEDAVİ HİZMETLERİ
ClinicalTrials.gov Identifier: NCT01382966     History of Changes
Other Study ID Numbers: RFM RENAL
Study First Received: June 21, 2011
Last Updated: June 27, 2011
Health Authority: Turkey: Ethics Committee

Keywords provided by RFM Renal Treatment Services:
sclerostin
arteriovenous fistula thrombosis
carpal tunnel syndrome
echocardiography

Additional relevant MeSH terms:
Rickets
Arteriovenous Fistula
Carpal Tunnel Syndrome
Hypertrophy
Kidney Diseases
Renal Osteodystrophy
Hypertrophy, Left Ventricular
Renal Insufficiency, Chronic
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Fistula
Pathological Conditions, Anatomical
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Urologic Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 28, 2014