NCT01325142

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 271 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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 description

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

Conditions

• Bone Diseases
• Metastases
• Osteonecrosis
• Bisphosphonate-Associated Osteonecrosis of the Jaw

Timeline

• Start date: 2010-08-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2011-03-29
• Last updated: 2014-12-02

Locations

1 site across 1 country: United States