DPBRN Retrospective Cohort Study of Osteonecrosis of the Jaw

NCT ID: NCT01201330

Last Updated: 2011-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

572606 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Osteonecrosis of the Jaw

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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ONJ sufferers

history of jaw osteonecrosis

No interventions assigned to this group

Bisphosphonate exposure

patients with exposure to bisphosphonates

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* ONJ sufferers and control biphosphonate users older than 40, of any gender, race and ethnic origin
Minimum Eligible Age

41 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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HealthPartners Institute

OTHER

Sponsor Role collaborator

Kaiser Permanente

OTHER

Sponsor Role collaborator

Permanente Dental Associates Group, Oregon

OTHER

Sponsor Role collaborator

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role collaborator

Dental Practice-Based Research Network

NETWORK

Sponsor Role lead

Responsible Party

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University of Alabama at Birmingham

Principal Investigators

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Jeffrey Fellows, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Andrei Barasch, DMD,MDSc

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Brad Rindal, DMD

Role: PRINCIPAL_INVESTIGATOR

HealthPartners of Minnesota

Gregg H Gilbert, DDS, MBA

Role: STUDY_CHAIR

University of Alabama School of Dentistry

Locations

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Gregg H. Gilbert, DDS, MBA

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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U01DE016747

Identifier Type: NIH

Identifier Source: secondary_id

View Link

106030

Identifier Type: -

Identifier Source: org_study_id

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