Bisphosphonate-Associated Jaw Osteonecrosis and PET Imaging
This study is ongoing, but not recruiting participants.
Sponsor:
University of Arkansas
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
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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-associated 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:
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) |
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.
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 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
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 22, 2012 |
| 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 May 19, 2013