Viewing Study NCT00403598



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Study NCT ID: NCT00403598
Status: UNKNOWN
Last Update Posted: 2006-11-27
First Post: 2006-11-23

Brief Title: Preliminary Study for Identification of Calcium-Binding Proteins in the Serum in Various Metabolic Bone Disorders
Sponsor: Sheba Medical Center
Organization: Sheba Medical Center

Study Overview

Official Title: None
Status: UNKNOWN
Status Verified Date: 2006-11
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: The purpose of this study is to determine whether the serum levels of certain calcium-binding proteins may be helpful in the diagnosis and management of metabolic bone diseases
Detailed Description: Osteoporosis is an important and costly health issue The diagnosis of the disease is based on measurement of bone mineral density or the occurrence of characteristic fractures Currently it is not possible to predict fractures in individual patients and the ability to monitor the response to treatment is limited as well

We have synthesized and characterized a novel photoreactive Ca2-analog reagent Azido ruthenium AzRu that binds covalently to Ca2-binding sites in proteins The specificity of AzRu for Ca2-binding proteins its photoactivation and its radioactive labeling pave the way for a wide use of AzRu as a powerful tool to assess Ca2-dependent cellular processes both in vitro and in vivo Using radiolabeled AzRu it will be possible to identify Ca2-binding proteins in a biological sample such as whole cell isolated mitochondria ER or other protein containing fractions Protein bound 103RuAzRu in biological sample can be separated by SDS gel electrophoresis followed by Coomassie staining and exposure of the dried gel to X-ray film autoradiography This allows the identification of the 103Ru radiolabeled proteins The labeled protein bands can be cut from the gel and subjected to MALADI-TOF analysis and the identity of the protein can be determined by a sequence homology search

These would allow detection of Ca2-binding proteins in the serum of various diseases and disorders potentially leading to identification of novel biomarkers for disease diagnostics

We would like to use blood samples to carry out the procedure described above for identification of Ca2 binding proteins appearing or their level is increased in disease or under pathogenic conditions Since Ca2 binding proteins play an important role in bone metabolism we chose to test their occurrence in the serum of patients with osteoporosis and other metabolic bone diseases

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