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Bisphosphonate-Associated Jaw Osteonecrosis and PET Imaging

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ClinicalTrials.gov Identifier: NCT00592982
Recruitment Status : Completed
First Posted : January 14, 2008
Last Update Posted : October 25, 2013
Information provided by (Responsible Party):
University of Arkansas

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.

Condition or disease
Bisphosphonate-associated ONJ Osteomyelitis of the Jaw Osteolytic Lesions of the Jaw Osteoradionecrosis of the Jaw

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 medical records of patients who have been diagnosed with jaw osteomyelitis, osteoradionecrosis, and cancerous lytic lesions who received 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 regarding the onset of symptoms, treatment interventions, and outcomes.

Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bisphosphonate-Associated Jaw Osteonecrosis and PET Imaging
Study Start Date : October 2006
Primary Completion Date : August 2013
Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteonecrosis
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary Care Clinic

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00592982

United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Principal Investigator: Brendan Stack, MD University of Arkansas

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
First Posted: January 14, 2008    Key Record Dates
Last Update Posted: October 25, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Bone Diseases
Musculoskeletal Diseases
Pathologic Processes
Bone Diseases, Infectious
Radiation Injuries
Wounds and Injuries
Bone Density Conservation Agents
Physiological Effects of Drugs