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. 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.

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Key information

Conditions

Osteoporosis, With or Without Treatment Atypical Femur Fracture Bisphosphonate Related Osteonecrosis of the Jaws (BRONJ) Bisphosphonate Treatment Bisphosphonate-Associated Osteonecrosis of the Jaw Bone Diseases Bone Diseases, Metabolic Healthy Volunteers Jaw Diseases Metabolic Diseases Musculoskeletal Diseases Necrosis Nutritional and Metabolic Diseases Osteonecrosis Osteoporosis Pathologic Processes Pathological Conditions, Signs and Symptoms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Absorption, Distribution, Metabolism, Excretion (ADME) Profiling of DNA from all sample types vs. normative data for the ADME panel and across study groups

Time frame: Baseline

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.

Secondary outcomes

Differential expression of miRNA biomarkers across participant groups within the study

Time frame: Baseline

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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Biomarker Identification in Orthopaedic and Oral Maxillofacial Subjects

Important dates

Study start: 2012
Primary completion: 2022
Study completion: 2022
First posted: Jun 11, 2013
Registry last updated: Jan 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed