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

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.

Full Title of Study: “Proposal For The Development Of A Well Defined Database For Patients With Oral Bisphosphonate-Related Osteonecrosis of the Jaws (BON)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: July 2011

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.

Interventions

  • Other: Observational
    • Group of patients with osteochemonecrosis related to oral bisphosphonate use

Arms, Groups and Cohorts

  • Observational
    • Group of patients with osteochemonecrosis related to oral bisphosphonate use

Clinical Trial Outcome Measures

Primary Measures

  • establish complete database and publish descriptive paper
    • Time Frame: 2 years

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Florida
  • Collaborator
    • Merck Sharp & Dohme Corp.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Donald M Cohen, DMD, MS, Principal Investigator, University of Florida

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