Proposal For The Development Of A Well Defined Database For Patients With Oral Bisphosphonate-Related Osteonecrosis
This study has been completed.
Sponsor:
University of Florida
Collaborator:
Merck
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
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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
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
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 Bone Diseases Musculoskeletal Diseases Necrosis Pathologic Processes |
Diphosphonates Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013