Bisphosphonate-Associated Jaw Osteonecrosis and PET Imaging

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-10-31

Study Completion Date

2013-08-31

Brief Summary

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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

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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.

Conditions

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Bisphosphonate-associated ONJ Osteomyelitis of the Jaw Osteolytic Lesions of the Jaw Osteoradionecrosis of the Jaw

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brendan Stack, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

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University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

Other Identifiers

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73319

Identifier Type: -

Identifier Source: org_study_id