Bisphosphonate-Associated Jaw Osteonecrosis and PET Imaging

This study is ongoing, but not recruiting participants.

First Received on December 27, 2007. Last Updated on October 4, 2011 History of Changes

Sponsor:	University of Arkansas
Information provided by (Responsible Party):	University of Arkansas
ClinicalTrials.gov Identifier:	NCT00592982

Purpose

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.

Condition
Bisphosphonate-asscoiated ONJ Osteomyelitis of the Jaw Osteolytic Lesions of the Jaw Osteoradionecrosis of the Jaw

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Bisphosphonate-Associated Jaw Osteonecrosis and PET Imaging

Resource links provided by NLM:

MedlinePlus related topics: Osteonecrosis

U.S. FDA Resources

Further study details as provided by University of Arkansas:

Estimated Enrollment:	1000
Study Start Date:	October 2006
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Primary Care Clinic

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592982

Locations

United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205

Sponsors and Collaborators

University of Arkansas

Investigators

Principal Investigator:

Brendan Stack, MD

University of Arkansas

More Information

Publications:

1. Osteonecrosis of the Jaw and Bisphosphonates 2005. NEJM 353: 99-102. 2. Marx RE. 2003 Pamidronate (AREDIA) and Zoledronate (ZOMETA) induced avascular necrosis of the jaws: a growing epidemic J Oral Maxillofac Surg 61:1115-1118 3. Hellstein JW, Marek CL. 2005. Bisphosphonate Osteochemonecrosis (Bis-Phossy Jaw): Is This Phossy Jaw of the 21st Century? J Oral Maxillofac Surg 63: 682-689. 4. Ruggiero SL, Mehrotra B, Rosenberg TJ, Engroff SL. 2004. Osteonecrosis of the Jaws Associated With the Use of Bisphosphonates: A Review of 63 Cases. J Oral Maxillofac Surg 62:527-534. 5. Clarke BM, Boyette JR, Vural EA, Suen JY, Anaisse EJ, Stack BC. Bisphosphonates and Jaw Osteonecrosis: Our Experience. Otolaryngol Head Neck Surg. 2007 Mar;136(3):396-400.

Responsible Party:	University of Arkansas
ClinicalTrials.gov Identifier:	NCT00592982 History of Changes
Other Study ID Numbers:	73319
Study First Received:	December 27, 2007
Last Updated:	October 4, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Osteomyelitis
Osteonecrosis
Osteoradionecrosis
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Necrosis

Pathologic Processes
Radiation Injuries
Wounds and Injuries
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012