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

University of Florida35 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Osteonecrosis

Interventions

ObservationalOTHER

Group of patients with osteochemonecrosis related to oral bisphosphonate use

Eligibility

Sex: ALLMin age: 30 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Florida

Gainesville, Florida, United States

Outcomes

Primary Outcomes

establish complete database and publish descriptive paper

Time frame: 2 years

Data from ClinicalTrials.gov

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