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

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

This study is currently recruiting participants.
Verified by University of Florida, September 2008

Sponsors and Collaborators:	University of Florida Merck
Information provided by:	University of Florida
ClinicalTrials.gov Identifier:	NCT00601068

Purpose

In cooperation with Merck & Co, Inc. we will identify and form a database of 25-30 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: alendronate

MedlinePlus related topics:

Osteonecrosis

Drug Information available for:

Alendronate Alendronate sodium

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Retrospective

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

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

Biospecimen Description:

biopsy tissue submitted from bone biopsies

Estimated Enrollment:	30
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Observation Group of patients with osteochemonecrosis related to oral bisphonate use	Other: alendronate observation of data collected of patients already on drug before study

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

Contacts


Contact: Donald M Cohen, DMD, MS	352-273-6695	dcohen@dental.ufl.edu

Contact: Risa M Cohen, MD, PhD	518-209-9015	risa.cohen@medicine.ufl.edu

Locations


United States, Florida
	University of Florida	Recruiting
	Gainesville, Florida, United States, 32610
	Principal Investigator: Donald M Cohen, DMD, MS

Sponsors and Collaborators

University of Florida

Merck

Investigators


Principal Investigator:	Donald M Cohen, DMD, MS	University of Florida

More Information

Responsible Party:	University of Florida ( Donald M. Cohen, Professor, PI )
Study ID Numbers:	32936, 00065255 UFID
First Received:	January 14, 2008
Last Updated:	September 16, 2008
ClinicalTrials.gov Identifier:	NCT00601068
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Florida:

osteonecrosis, jaws, bisphosphonate, fosamax, alendronate

Study placed in the following topic categories:

Necrosis

Diphosphonates

Musculoskeletal Diseases

Osteonecrosis

Alendronate

Bone Diseases

Additional relevant MeSH terms:

Pathologic Processes

Physiological Effects of Drugs

Bone Density Conservation Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 28, 2008