DPBRN Retrospective Cohort Study of Osteonecrosis of the Jaw

June 14, 2011 updated by: Dental Practice-Based Research Network

Retrospective Cohort Study of ONJ

The purpose of this study was to determine the prevalence of ONJ in the patient population of 2 large HMOs and study the risk factors associated with the development of this condition.

Study Overview

Status

Completed

Conditions

Detailed Description

The electronic database from Kaiser Permanente and HealthParnters of Minnesota were used to identify all ONJ cases that occured between 1994 and 2006 and then demographic, social and medical risk factors possibly associated with the disease were abstracted and analyzed.

Study Type

Observational

Enrollment (Actual)

572606

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
    • Alabama
      • Birmingham, Alabama, United States, 35294-0007
        • Gregg H. Gilbert, DDS, MBA

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

41 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients older than 40 with a history of jaw osteonecrosis and control patients with exposure to biphosphonates were included.

Description

Inclusion Criteria:

  • ONJ sufferers and control biphosphonate users older than 40, of any gender, race and ethnic origin

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
ONJ sufferers
history of jaw osteonecrosis
Bisphosphonate exposure
patients with exposure to bisphosphonates

Collaborators and Investigators

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

Sponsor

Dental Practice-Based Research Network

Collaborators

National Institute of Dental and Craniofacial Research (NIDCR)
HealthPartners Institute
Kaiser Permanente
Permanente Dental Associates Group, Oregon

Investigators

  • Principal Investigator: Jeffrey Fellows, Ph.D., Kaiser Permanente
  • Principal Investigator: Andrei Barasch, DMD,MDSc, University of Alabama at Birmingham
  • Principal Investigator: Brad Rindal, DMD, HealthPartners of Minnesota
  • Study Chair: Gregg H Gilbert, DDS, MBA, University of Alabama School of Dentistry

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

January 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

September 13, 2010

First Submitted That Met QC Criteria

September 13, 2010

First Posted (Estimate)

September 14, 2010

Study Record Updates

Last Update Posted (Estimate)

June 16, 2011

Last Update Submitted That Met QC Criteria

June 14, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 106030
  • U01DE016747 (U.S. NIH Grant/Contract)

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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