Proposal For The Development Of A Well Defined Database For Patients With Oral Bisphosphonate-Related Osteonecrosis
Completed
- Conditions
- Osteonecrosis
- Interventions
- Other: Observational
- Registration Number
- NCT00601068
- Lead Sponsor
- University of Florida
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Observational Observational Group of patients with osteochemonecrosis related to oral bisphosphonate use
- Primary Outcome Measures
Name Time Method establish complete database and publish descriptive paper 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Florida
🇺🇸Gainesville, Florida, United States