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DPBRN Retrospective Cohort Study of Osteonecrosis of the Jaw

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ClinicalTrials.gov Identifier: NCT01201330
Recruitment Status : Completed
First Posted : September 14, 2010
Last Update Posted : June 16, 2011
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease
Osteonecrosis of the Jaw

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 Design

Study Type : Observational
Actual Enrollment : 572606 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Cohort Study of ONJ
Study Start Date : January 2007
Primary Completion Date : May 2008
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteonecrosis
U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   41 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01201330

United States, Alabama
Gregg H. Gilbert, DDS, MBA
Birmingham, Alabama, United States, 35294-0007
Sponsors and Collaborators
Dental Practice-Based Research Network
HealthPartners Institute
Kaiser Permanente
Permanente Dental Associates Group, Oregon
National Institute of Dental and Craniofacial Research (NIDCR)
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
More Information

Responsible Party: Gregg H. Gilbert, DDS, MBA, Study Chair, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01201330     History of Changes
Other Study ID Numbers: 106030
U01DE016747 ( U.S. NIH Grant/Contract )
First Posted: September 14, 2010    Key Record Dates
Last Update Posted: June 16, 2011
Last Verified: June 2011

Keywords provided by Dental Practice-Based Research Network:

Additional relevant MeSH terms:
Bone Diseases
Musculoskeletal Diseases
Pathologic Processes