Proposal For The Development Of A Well Defined Database For Patients With Oral Bisphosphonate-Related Osteonecrosis

Proposal For The Development Of A Well Defined Database For Patients With Oral Bisphosphonate-Related Osteonecrosis of the Jaws (BON)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00601068

Enrollment

Registered

2008-01-25

Start date

2007-12-31

Completion date

2011-07-31

Last updated

2013-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteonecrosis

Keywords

osteonecrosis, jaws, bisphosphonate, fosamax, alendronate

Brief summary

In cooperation with Merck & Co, Inc. we will identify and form a database of 35 patients who have developed osteochemonecrosis of the jaws related to oral bisphosphonate use. We will study the triggers, associated medical conditions and medications, location of the lesion(s), and patient outcomes.

Detailed description

This study is an observational study, and not a comparative trial. The major outcome is represented by the fraction of subjects with long term healed lesions.

Interventions

OTHERObservational

Group of patients with osteochemonecrosis related to oral bisphosphonate use

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Exposed bone in the oral cavity of greater than 6-8 weeks duration unresponsive to therapy

Exclusion criteria

* Pregnant patients * Patients less than 30 yrs of age or greater than 90 yrs of age * Mentally incompetent individuals

Design outcomes

Primary

Measure	Time frame
establish complete database and publish descriptive paper	2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026