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

Osteoporosis Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00403598
• Other study ID #: SHEBA-06-4372-IV-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: November 23, 2006
• Last updated: November 23, 2006

Study information

• Verified date: November 2006
• Source: Sheba Medical Center
• Contact: Iris Vered, MD
• Phone: 972-3-5303103
• Email: iris.vered[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of a metabolic bone disorder

Exclusion Criteria:

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Osteitis Deformans
• Osteoporosis
• Parathyroid Diseases

Locations

Country	Name	City	State
Israel	Sheba Medical Center, Tel Hashomer	Ramat Gan

Sponsors (2)

Lead Sponsor	Collaborator
Sheba Medical Center	Ben-Gurion University of the Negev

Country where clinical trial is conducted

Israel,