Serum Sclerostin Levels, Cardiovascular Parameters and Carpal Tunnel Syndrome in Maintenance Hemodialysis Patients
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ClinicalTrials.gov Identifier: NCT01382966 |
Recruitment Status
: Unknown
Verified June 2011 by RFM Renal Treatment Services.
Recruitment status was: Not yet recruiting
First Posted
: June 27, 2011
Last Update Posted
: June 28, 2011
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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 or disease |
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Chronic Kidney Disease Renal Osteodystrophy Left Ventricular Hypertrophy |
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.
Study Type : | Observational |
Estimated Enrollment : | 400 participants |
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 |
Study Start Date : | July 2011 |
Estimated Primary Completion Date : | September 2011 |
Estimated Study Completion Date : | October 2011 |

Group/Cohort |
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Single group
Maintenance hemodialysis patients of minimal 6 months of hemodialysis duration; free of malignancy, infection and autoimmune disease; age over 18 years
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- Number of Participants with left ventricular hypertrophy or left ventricular dysfunction according to tertiles of the serum sclerostin levels [ Time Frame: 3 months ]
- Number of Participants with arteriovenous fistula thrombosis [ Time Frame: 3 months ]
- Number of Participants with carpal tunnel syndrome according to tertiles of the serum sclerostin levels [ Time Frame: 3 months ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Maintenance hemodialysis patients (minimum 6 months of duration)
- Willingness
- Age > 18 years
Exclusion Criteria:
- Infection
- Malignancy
- Autoimmune disease

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01382966
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 |
Principal Investigator: | ALPER KIRKPANTUR, MD | RFM Renal Treatment Services |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | RFM RENAL TEDAVİ HİZMETLERİ |
ClinicalTrials.gov Identifier: | NCT01382966 History of Changes |
Other Study ID Numbers: |
RFM RENAL |
First Posted: | June 27, 2011 Key Record Dates |
Last Update Posted: | June 28, 2011 |
Last Verified: | June 2011 |
Keywords provided by RFM Renal Treatment Services:
sclerostin arteriovenous fistula thrombosis carpal tunnel syndrome echocardiography |
Additional relevant MeSH terms:
Kidney Diseases Renal Insufficiency, Chronic Carpal Tunnel Syndrome Hypertrophy Arteriovenous Fistula Hypertrophy, Left Ventricular Chronic Kidney Disease-Mineral and Bone Disorder Urologic Diseases Renal Insufficiency Median Neuropathy Mononeuropathies Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Nerve Compression Syndromes |
Cumulative Trauma Disorders Sprains and Strains Wounds and Injuries Pathological Conditions, Anatomical Arteriovenous Malformations Vascular Malformations Cardiovascular Abnormalities Cardiovascular Diseases Vascular Fistula Vascular Diseases Congenital Abnormalities Fistula Cardiomegaly Heart Diseases Rickets |