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Bisphosphonate-Associated Jaw Osteonecrosis and PET Imaging

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00592982
First received: December 27, 2007
Last updated: October 22, 2012
Last verified: October 2012
History of Changes

December 27, 2007
October 22, 2012
October 2006
June 2013   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00592982 on ClinicalTrials.gov Archive Site
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Bisphosphonate-Associated Jaw Osteonecrosis and PET Imaging
Bisphosphonate-Associated Jaw Osteonecrosis and PET Imaging
  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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Primary Care Clinic
  • Bisphosphonate-associated ONJ
  • Osteomyelitis of the Jaw
  • Osteolytic Lesions of the Jaw
  • Osteoradionecrosis of the Jaw
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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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1000
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00592982
73319
No
University of Arkansas
University of Arkansas
Not Provided
Principal Investigator: Brendan Stack, MD University of Arkansas
University of Arkansas
October 2012

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