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

NCT ID: NCT00601068

Last Updated: 2013-01-04

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

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-12-31

Study Completion Date

2011-07-31

Brief Summary

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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

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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.

Conditions

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Osteonecrosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Observational

Group of patients with osteochemonecrosis related to oral bisphosphonate use

Observational

Intervention Type OTHER

Group of patients with osteochemonecrosis related to oral bisphosphonate use

Interventions

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Observational

Group of patients with osteochemonecrosis related to oral bisphosphonate use

Intervention Type OTHER

Other Intervention Names

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Osteochemonecrosis

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Donald M Cohen, DMD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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00065255 UFID

Identifier Type: -

Identifier Source: secondary_id

32936

Identifier Type: -

Identifier Source: org_study_id

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