Biomarker Identification in Orthopaedic & Oral Maxillofacial Surgery Subjects to Identify Risks of Bisphosphonate Use

Healthy Volunteers Clinical Trial

Official title:

Biomarker Identification in Orthopaedic and Oral Maxillofacial Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01875458
• Other study ID #: 815570
• Secondary ID: 815570
• Status: Completed
• Start date: April 13, 2012
• Est. completion date: October 30, 2022

Study information

• Verified date: January 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Collected specimens were subjected to Affymetrix DMET™ Plus Solution analysis. Manuscript is in preparation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 314
• Est. completion date: October 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Any adult (male or female) age 18 or over meeting any of the following criteria:

• All participants must be able to provide informed consent for themselves.

• History of BP treatment with or without BRONJ and/or Femur fracture (typical or atypical)

• No History of BP treatment with or without BRONJ and/or Femur fracture (typical or atypical)

Exclusion Criteria:

• Children age 17 or younger

• Adults who cannot or do not make medical decisions for themselves

• Persons known to be under the jurisdiction of the Department of Corrections

• Individuals who are pregnant.

Related Conditions & MeSH terms

• Atypical Femur Fracture
• Bisphosphonate Related Osteonecrosis of the Jaws (BRONJ)
• Bisphosphonate Treatment
• Bisphosphonate-Associated Osteonecrosis of the Jaw
• Femoral Fractures
• Healthy Volunteers
• Osteonecrosis
• Osteoporosis
• Osteoporosis, With or Without Treatment

Locations

Country	Name	City	State
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absorption, Distribution, Metabolism, Excretion (ADME) Profiling of DNA from all sample types vs. normative data for the ADME panel and across study groups	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.	Baseline
Secondary	Differential expression of miRNA biomarkers across participant groups within the study	The relative abundance of miRNA across each participant subgroup will be compared using ANOVA modeling. Each participant subgroup will be compared to normative data for the distribution of miRNA expression profiles in the general population for each probe when available.	Baseline