Clinical Trial: Genetic Risk of Osteonecrosis of the Jaw (ONJ) in Patients With Metastatic Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Genetic Risk of Osteonecrosis of the Jaw (ONJ) in Patients With Metastatic Cancer

Brief Summary: This study seeks to identify risk factors associated with the development of a jaw condition seen in patients with cancer treated with certain medications.

Detailed Summary:

The goal of this research is to build an index of risk for estimating an individual's risk of developing osteonecrosis of the jaw (ONJ). The bisphosphonates are an important supportive therapy in the care of patients with metastatic bone disease; they are able to prevent catastrophic events such as fracture and spinal cord compression. However, ONJ has been associated with the use of the bisphosphonates and ONJ carries significant morbidity. Presently, there are insufficient data to calculate the ONJ risk benefit ratio of bisphosphonate use. An ONJ risk assessment tool would improve both the oncologist's and the dental health professional the ability to anticipate and potentially mitigate oral toxicities from bisphosphonate therapy.

This protocol consists of a case (ONJ) control (no ONJ) study to identify factors associated with the risk of ONJ and to build an index predictive of an individual's risk of developing ONJ. The index of ONJ risk will be comprised of clinical, epidemiologic and genetic factors


Sponsor: University of Michigan

Current Primary Outcome:

  • To identify clinical and epidemiologic characteristics associated with ONJ in patients with metastatic bone disease treated with a nitrogen containing bisphosphonate. [ Time Frame: 2009-2014 ]
    analysis is ongoing
  • To identify single nucleotide polymorphisms (SNPs) in genes affected by osteoclast inhibiting therapy that are associated with an increased risk of developing ONJ in patients with metastatic bone disease treated with nitrogen containing bisphosphonates. [ Time Frame: 2009-2014 ]
    analysis is ongoing
  • To generate a multifactorial index of ONJ risk by multivariate analysis of the clinical, epidemiologic and genetic factors [ Time Frame: 2009-2014 ]
    analysis is ongoing


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Michigan

Dates:
Date Received: March 28, 2011
Date Started: August 2010
Date Completion:
Last Updated: December 1, 2014
Last Verified: December 2014