NCT00601068

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 14, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 25, 2008

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

January 4, 2013

Status Verified

July 1, 2012

Enrollment Period

3.6 years

First QC Date

January 14, 2008

Last Update Submit

January 3, 2013

Conditions

Osteonecrosis

Keywords

osteonecrosis, jaws, bisphosphonate, fosamax, alendronate

Outcome Measures

Primary Outcomes (1)

  • establish complete database and publish descriptive paper

    2 years

Study Arms (1)

Observational

Group of patients with osteochemonecrosis related to oral bisphosphonate use

Other: Observational

Interventions

ObservationalOTHER

Group of patients with osteochemonecrosis related to oral bisphosphonate use

Also known as: Osteochemonecrosis
Observational

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Exposed bone in the oral cavity of greater than 6-8 weeks duration unresponsive to therapy

You may not qualify if:

  • Pregnant patients
  • Patients less than 30 yrs of age or greater than 90 yrs of age
  • Mentally incompetent individuals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

biopsy tissue submitted from bone biopsies

MeSH Terms

Conditions

Osteonecrosis

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Donald M Cohen, DMD, MS

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2008

First Posted

January 25, 2008

Study Start

December 1, 2007

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

January 4, 2013

Record last verified: 2012-07

Locations

US(1)