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

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.

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Key information

Conditions

Osteonecrosis Bone Diseases Musculoskeletal Diseases Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

30 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational

Other

Group of patients with osteochemonecrosis related to oral bisphosphonate use

Other names: Osteochemonecrosis

Primary outcomes

establish complete database and publish descriptive paper

Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

Merck Sharp & Dohme LLC

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2011
Study completion: 2011
First posted: Jan 25, 2008
Registry last updated: Jan 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed