Proposal For The Development Of A Well Defined Database For Patients With Oral Bisphosphonate-Related Osteonecrosis

University of Florida

Status: Completed

Conditions: Osteonecrosis

Treatments: Other: Observational

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00601068

32936

00065255 UFID

Details and patient eligibility

About

In cooperation with Merck & Co, Inc. we will identify and form a database of 35 patients who have developed osteochemonecrosis of the jaws related to oral bisphosphonate use. We will study the triggers, associated medical conditions and medications, location of the lesion(s), and patient outcomes.

Full description

This study is an observational study, and not a comparative trial. The major outcome is represented by the fraction of subjects with long term healed lesions.

Enrollment: 35 patients

Sex: All

Ages: 30 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Exposed bone in the oral cavity of greater than 6-8 weeks duration unresponsive to therapy

Exclusion criteria

• Pregnant patients
• Patients less than 30 yrs of age or greater than 90 yrs of age
• Mentally incompetent individuals

Trial design

35 participants in 1 patient group

Observational

Description:

Group of patients with osteochemonecrosis related to oral bisphosphonate use

Treatment:

Other: Observational