NCT00592982

Brief Summary

  1. 1.Bisphosphonate-associated osteonecrosis of the jaw(ONJ)is detectable by positron emission tomography(PET).
  2. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 27, 2007

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 14, 2008

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

October 25, 2013

Status Verified

October 1, 2013

Enrollment Period

6.8 years

First QC Date

December 27, 2007

Last Update Submit

October 24, 2013

Conditions

Bisphosphonate-associated ONJOsteomyelitis of the JawOsteolytic Lesions of the JawOsteoradionecrosis of the Jaw

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary Care Clinic

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (1)

  • 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.

    BACKGROUND

Study Officials

  • Brendan Stack, MD

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2007

First Posted

January 14, 2008

Study Start

October 1, 2006

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

October 25, 2013

Record last verified: 2013-10

Locations

US(1)