Performance Evaluation of the Micromedic BRONJ Risk Assessment in Vitro Diagnostic Assay — BRONJ  

Bisphosphonate-related Osteonecrosis of the Jaw Clinical Trial

Official title: Performance Evaluation of the Micromedic BRONJ Risk Assessment in Vitro Diagnostic Assay.

Status Recruiting

Clinical Trial Summary

To evaluate the performance of the Micromedic BRONJ Risk Assessment in vitro assay (the "BRONJ Assay") in identifying Multiple Myeloma (MM) and/or other cancer subjects at risk for developing Bisphosphonate-related Osteonecrosis of the Jaw (BRONJ) following intravenous (IV) administration of Bisphosphonates (BP).

Clinical Trial Description

The Micromedic BRONJ Assay is intended for the qualitative analysis of genetic changes which may be indicative of increased risk to develop BRONJ osteonecrosis of the jaw (ONJ) following IV administration of drugs of the Bisphosphonate family. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bisphosphonate-Associated Osteonecrosis of the Jaw
• Bisphosphonate-related Osteonecrosis of the Jaw
• Osteonecrosis

• NCT number: NCT02218554
• Study type: Interventional
• Source: Micromedic Technologies Ltd
• Contact: Noam Yarom, Dr.
• Phone: 972-35303819
• Email: noamyar@post.tau.ac.il
• Status: Recruiting
• Phase: N/A
• Start date: January 2012
• Completion date: December 2014