DPBRN Retrospective Cohort Study of Osteonecrosis of the Jaw | NCT01201330

Studies
DPBRN Retrospective Cohort Study of Osteonecrosis of the Jaw

NCT01201330

Sponsor

Dental Practice-Based Research Network

Status

Completed

Last Update Posted

Jun 16, 2011Estimated

Enrollment

572,606Actual

Phase

Not provided

Conditions

Osteonecrosis of the Jaw

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U01DE016747	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

May 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Sep 13, 2010

First Submission Date that Met QC Criteria

Sep 13, 2010

First Posted Date

Sep 14, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2011

Last Update Posted Date

Jun 16, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Dental Practice-Based Research NetworkNETWORK

Collaborators

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

572,606Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ONJ sufferers		history of jaw osteonecrosis
Bisphosphonate exposure		patients with exposure to bisphosphonates

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

41 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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	Principal Investigator
Gregg H Gilbert, DDS, MBA	University of Alabama School of Dentistry	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gregg H. Gilbert, DDS, MBA		Birmingham	Alabama	35294-0007	United States