NCT01201330

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
572,606

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2010

Completed
Last Updated

June 16, 2011

Status Verified

June 1, 2011

Enrollment Period

1.3 years

First QC Date

September 13, 2010

Last Update Submit

June 14, 2011

Conditions

Osteonecrosis of the Jaw

Keywords

ONJ

Study Arms (2)

ONJ sufferers

history of jaw osteonecrosis

Bisphosphonate exposure

patients with exposure to bisphosphonates

Eligibility Criteria

Age41 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gregg H. Gilbert, DDS, MBA

Birmingham, Alabama, 35294-0007, United States

Location

Study Officials

  • 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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK

Study Record Dates

First Submitted

September 13, 2010

First Posted

September 14, 2010

Study Start

January 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

June 16, 2011

Record last verified: 2011-06

Locations

US(1)