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Preliminary Study for Identification of Calcium-Binding Proteins in the Serum in Various Metabolic Bone Disorders

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2006 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00403598
First Posted: November 27, 2006
Last Update Posted: November 27, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ben-Gurion University of the Negev
Information provided by:
Sheba Medical Center
  Purpose
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.

Condition
Osteoporosis Osteitis Deformans Parathyroid Diseases

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Time Perspective: Retrospective/Prospective

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

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 [103Ru]AzRu 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of a metabolic bone disorder

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

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): NCT00403598


Contacts
Contact: Iris Vered, MD 972-3-5303103 iris.vered@sheba.health.gov.il
Contact: Varda Shoshan-Barmatz, Ph.D 972-8-6461336 vardasb@bgu.ac.il

Locations
Israel
Sheba Medical Center, Tel Hashomer Not yet recruiting
Ramat Gan, Israel, 52621
Principal Investigator: Iris Vered, M.D         
Sponsors and Collaborators
Sheba Medical Center
Ben-Gurion University of the Negev
Investigators
Principal Investigator: Iris Vered, M.D Sheba Medical Center, Tel Hashomer
  More Information

ClinicalTrials.gov Identifier: NCT00403598     History of Changes
Other Study ID Numbers: SHEBA-06-4372-IV-CTIL
First Submitted: November 23, 2006
First Posted: November 27, 2006
Last Update Posted: November 27, 2006
Last Verified: November 2006

Additional relevant MeSH terms:
Osteoporosis
Parathyroid Diseases
Osteitis
Osteitis Deformans
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Endocrine System Diseases