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Bisphosphonate-Associated Jaw Osteonecrosis and PET Imaging

This study is ongoing, but not recruiting participants.
Study NCT00592982.   Last updated on December 27, 2007.   Information provided by University of Arkansas

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Descriptive Information Fields
Brief Title  Bisphosphonate-Associated Jaw Osteonecrosis and PET Imaging
Official Title  Bisphosphonate-Associated Jaw Osteonecrosis and PET Imaging
Brief Summary
  1. Bisphosphonate-associated osteonecrosis of the jaw(ONJ)is detectable by positron emission tomography(PET).
  2. 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  Observational
Study Design  Cohort, Prospective
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Bisphosphonate-Asscoiated ONJ
Osteomyelitis of the Jaw
Osteolytic Lesions of the Jaw
Osteoradionecrosis of the Jaw
Intervention 
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  1000
Start Date  October 2006
Completion Date October 2009
Eligibility 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00592982
Organization ID 73319
Secondary IDs ††
Study Sponsor  University of Arkansas
Collaborators ††
Investigators 
Principal Investigator:     Brendan Stack, MD     University of Arkansas    
Information Provided By University of Arkansas
Verification Date December 2007
First Received Date  December 27, 2007
Last Updated Date December 27, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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