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

January 3, 2013 updated by: University of Florida

Proposal For The Development Of A Well Defined Database For Patients With Oral Bisphosphonate-Related Osteonecrosis of the Jaws (BON)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients who develop exposed bone in their mouth and are on an oral bisphosphonate

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational
Group of patients with osteochemonecrosis related to oral bisphosphonate use
Other: Observational
Group of patients with osteochemonecrosis related to oral bisphosphonate use
Other Names:
  • Osteochemonecrosis

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Donald M Cohen, DMD, MS, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

January 14, 2008

First Submitted That Met QC Criteria

January 24, 2008

First Posted (Estimate)

January 25, 2008

Study Record Updates

Last Update Posted (Estimate)

January 4, 2013

Last Update Submitted That Met QC Criteria

January 3, 2013

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 32936
  • 00065255 UFID

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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