Trials / Completed
CompletedNCT01875458
Biomarker Identification in Orthopaedic & Oral Maxillofacial Surgery Subjects to Identify Risks of Bisphosphonate Use
Biomarker Identification in Orthopaedic and Oral Maxillofacial Subjects
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 314 (actual)
- Sponsor
- University of Pennsylvania · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
Bisphosphonates are drugs that prevent bone loss by blocking the activity of cells that normally resorb bone. The most common examples of these drugs are Boniva and Fosamax. These drugs are available for oral or intravenous dosing and are prescribed at daily, weekly, biweekly, or monthly intervals. Among the many thousands of individuals who currently take these medications, certain individuals experience "atypical" femur fractures preceded by prodromal pain, changes in cortical thickening of bone, or bisphosphonate related osteonecrosis of the jaws (BRONJ). Osteonecrosis of the jaws is defined as exposed bone of the jaws for 8 weeks or more and requires surgical treatment. This study will attempt to identify genomic and rna biomarkers that may play a role in differential metabolism of bisphosphonates or indicate tendency toward the severe adverse events associated with these drugs.
Detailed description
Collected specimens were subjected to Affymetrix DMET™ Plus Solution analysis. Manuscript is in preparation.
Conditions
- Osteoporosis, With or Without Treatment
- Bisphosphonate Treatment
- Atypical Femur Fracture
- Bisphosphonate Related Osteonecrosis of the Jaws (BRONJ)
- Healthy Volunteers
Timeline
- Start date
- 2012-04-13
- Primary completion
- 2022-10-30
- Completion
- 2022-10-30
- First posted
- 2013-06-11
- Last updated
- 2023-01-13
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01875458. Inclusion in this directory is not an endorsement.