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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00601068
First received: January 14, 2008
Last updated: January 3, 2013
Last verified: July 2012
  Purpose

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.


Condition Intervention
Osteonecrosis
Other: Observational

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Proposal For The Development Of A Well Defined Database For Patients With Oral Bisphosphonate-Related Osteonecrosis of the Jaws (BON)

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • establish complete database and publish descriptive paper [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

biopsy tissue submitted from bone biopsies


Enrollment: 35
Study Start Date: December 2007
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Observational
Group of patients with osteochemonecrosis related to oral bisphosphonate use
Other: Observational
Group of patients with osteochemonecrosis related to oral bisphosphonate use
Other Name: Osteochemonecrosis

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.

  Eligibility

Ages Eligible for Study:   30 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients who develop exposed bone in their mouth and are on an oral bisphosphonate

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601068

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Donald M Cohen, DMD, MS University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00601068     History of Changes
Other Study ID Numbers: 32936, 00065255 UFID
Study First Received: January 14, 2008
Last Updated: January 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
osteonecrosis, jaws, bisphosphonate, fosamax, alendronate

Additional relevant MeSH terms:
Osteonecrosis
Bisphosphonate-Associated Osteonecrosis of the Jaw
Bone Diseases
Musculoskeletal Diseases
Necrosis
Pathologic Processes
Jaw Diseases
Stomatognathic Diseases
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014