Clinical Trials Logo
  1. Home
  2. Osteonecrosis
  3. NCT00601068
  4. Details
NCT00601068 Clinical Trial

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

Osteonecrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00601068
Other study ID # 32936
Secondary ID 00065255 UFID
Status Completed
Phase N/A
First received January 14, 2008
Last updated January 3, 2013
Start date December 2007
Est. completion date July 2011

Study information
Verified date July 2012
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 90 Years
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

  • Bisphosphonate-Associated Osteonecrosis of the Jaw
  • Osteonecrosis

Intervention

Other:
• Observational
Group of patients with osteochemonecrosis related to oral bisphosphonate use

Locations
Country Name City State
United States University of Florida Gainesville Florida

Sponsors (2)
Lead Sponsor Collaborator
University of Florida Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary establish complete database and publish descriptive paper 2 years No
See also
  Status Clinical Trial Phase
Terminated NCT04072055 - MOTO Post-marketing Surveillance Study
Terminated NCT02941666 - Human Mesenchymal Stem Cells in the Synovial Fluid of the Hip
Terminated NCT01763684 - Oxford Signature vs. Conventional Global Study N/A
Completed NCT00505219 - Ixmyelocel-T Treatment of Patients With Osteonecrosis of the Femoral Head Phase 3
Withdrawn NCT02632903 - Intravenous Zoledronic Acid for the Treatment of Osteoporosis and Osteonecrosis in Children With Leukemia: A Pilot Study Phase 2
Active, not recruiting NCT01458782 - ACI-C Versus AMIC. A Randomized Trial Comparing Two Methods for Repair of Cartilage Defects in the Knee N/A
Completed NCT01583465 - Efficacy of Aquamantys for Reducing Transfusions With Anterior Supine Intermuscular Approach Total Hip Arthroplasty N/A
Active, not recruiting NCT04401267 - Hypertension Intervention to Reduce Osteonecrosis in Children With Acute Lymphoblastic Leukemia/Lymphoma Phase 2
Completed NCT03197623 - Safety and Tolerability of Intravenous LLP2A-Alendronate for Osteopenia Secondary to Glucocorticoids Phase 1
Active, not recruiting NCT05283148 - Sickle Cell Disease (SCD) Bone Pain Study N/A
Completed NCT05684588 - Post-COVID-19 Sequelae: Osteonecrosis of Femoral Head N/A
Terminated NCT03269409 - Use of Adipose Derived Regenerative Cells in Bilateral Femoral Head Osteonecrosis Phase 1
Completed NCT00913679 - A Comparison of Two Different Surgical Techniques in Hip Resurfacing Arthroplasty N/A
Enrolling by invitation NCT02893293 - Imaging of Osteonecrosis With Ferumoxytol-Enhanced MRI Phase 4
Completed NCT01345097 - A Short Metaphyseal Fitting Total Hip Arthroplasty in Young and Elderly Patients Phase 4
Recruiting NCT00260897 - Molecular Genetic Study of Avascular Necrosis of the Femoral Head N/A
Not yet recruiting NCT06016634 - Alendronate for Osteonecrosis in Adults With Sickle Cell Disease Phase 2
Completed NCT02077647 - Focused Registry on the Conservative Treatment of Osteoarthritis of the Knee
Recruiting NCT01619124 - Osteonecroses in Pediatric Patients With ALL N/A
Completed NCT02458937 - Functional Outcomes Following Hip Core Decompression in Younger Participants With Osteonecrosis