Bisphosphonate-Associated Jaw Osteonecrosis and PET Imaging - Tabular View

Tracking Information

First Received Date ^ICMJE

December 27, 2007

Last Updated Date

December 27, 2007

Start Date ^ICMJE

October 2006

Estimated Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Bisphosphonate-Associated Jaw Osteonecrosis and PET Imaging

Official Title ^ICMJE

Bisphosphonate-Associated Jaw Osteonecrosis and PET Imaging

Brief Summary

Bisphosphonate-associated osteonecrosis of the jaw(ONJ)is detectable by positron emission tomography(PET).
Bisphosphonate-associated ONJ can be diagnosed and characteristically differentiated from other bony pathologies of the jaw(osteomyelitis, osteolytic lesions, and osteoradionecrosis)by PET imaging.

Detailed Description

Is to review medical records of approximately 1000 patients with bisphosphonate-associated ONJ who have had PET imaging at the time of diagnosis. Also to review mediacl records of patients who have been diagnosed with jaw osteomyelitis, osteoradionecrosis, and cancerous lytic lesions who recieved PET imaging at the time of diagnosis.

If sufficient information regarding presentation and treatment cannot be obtained form the medical record, approximately 300 patients will contacted by mail (and phone if necessary) by the PI or sub-investigators to question them reguarding the onset of symptoms, treatment interventions, and outcomes.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Cohort, Prospective

Condition ^ICMJE

Bisphosphonate-Asscoiated ONJ
Osteomyelitis of the Jaw
Osteolytic Lesions of the Jaw
Osteoradionecrosis of the Jaw

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

1000

Estimated Completion Date

October 2009

Estimated Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosis of bisphosphonate-associated ONJ, osteomyelitis, osteoradionecrosis,and osteolytic lesions who recieveed PET imaging at presentation

Exclusion Criteria:

Anyone who has not been diagnosed with bisphosphonate-associated ONJ, osteomyelitis, osteoradionecrosis,or osteolytic lesions who recieved PET imaging at presentation

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00592982

Responsible Party

Brendan Stack, MD, University of Arkansas for Medical Sciences

Study ID Numbers ^ICMJE

73319

Study Sponsor ^ICMJE

University of Arkansas

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Brendan Stack, MD

University of Arkansas

Information Provided By

University of Arkansas

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP