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NCT01875458 · ClinicalTrials.gov registry record
Biomarker Identification in Orthopaedic & Oral Maxillofacial Surgery Subjects to Identify Risks of Bisphosphonate Use
A clinical trial, sponsored by University of Pennsylvania.
- Completed
- Registry status
- 314
- Enrollment target
NCT01875458: Completed study, sponsored by University of Pennsylvania.
NCT01875458 is a clinical trial that has completed, run by University of Pennsylvania. The registered enrollment target is 314 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01875458 has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- 314 participants
- Enrollment target
Study 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.
Primary Outcome
DNA analysis of saliva, blood, and tissues to detect differential response to drugs. DNA will be isolated from each sample and ADME profiling will be performed. Each participant subgroup will be compared to each other using ANOVA modeling. Each participant subgroup will be compared to normative data for the distribution of gene profiles in the general population for each probe on the ADME gene array.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 314 participants |
| Start Date | 2012-04-13 |
| Est. Completion | 2022-10-30 |
What the finished NCT01875458 record still lists
NCT01875458 is an observational study that tracks outcomes without assigning an intervention. The registered 314 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01875458 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01875458 about?
NCT01875458 is a clinical study titled "Biomarker Identification in Orthopaedic & Oral Maxillofacial Surgery Subjects to Identify Risks of Bisphosphonate Use". 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. ...
What is the current status of trial NCT01875458?
This trial is currently completed. The enrollment target is 314 participants. The study started on 2012-04-13. Estimated completion is 2022-10-30.
Who is sponsoring clinical trial NCT01875458?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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