DPBRN Retrospective Cohort Study of Osteonecrosis of the Jaw

Osteonecrosis of the Jaw Clinical Trial

Official title:

Retrospective Cohort Study of ONJ

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01201330
• Other study ID #: 106030
• Secondary ID: U01DE016747
• Status: Completed
• Phase: N/A
• First received: September 13, 2010
• Last updated: June 14, 2011
• Start date: January 2007
• Est. completion date: May 2008

Study information

• Verified date: June 2011
• Source: Dental Practice-Based Research Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 572606
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 41 Years and older

Eligibility

Inclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Osteonecrosis
• Osteonecrosis of the Jaw

Locations

Country	Name	City	State
United States	Gregg H. Gilbert, DDS, MBA	Birmingham	Alabama

Sponsors (5)

Lead Sponsor	Collaborator
Dental Practice-Based Research Network	HealthPartners Institute, Kaiser Permanente, National Institute of Dental and Craniofacial Research (NIDCR), Permanente Dental Associates Group, Oregon

Country where clinical trial is conducted

United States,