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

University of Pennsylvania

Status: Completed

Conditions: Healthy Volunteers; Bisphosphonate Related Osteonecrosis of the Jaws (BRONJ); Atypical Femur Fracture; Bisphosphonate Treatment; Osteoporosis, With or Without Treatment

Study type: Observational

Funder types: Other

Identifiers

NCT01875458

815570 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 314 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

314 participants in 4 patient groups

CASES

Description:

Adults with current or past history of bisphosphonate treatment (exposed) with Bisphosphonate related Osteonecrosis of the Jaws (BRONJ), or, Adults with current or past history of bisphosphonate treatment (exposed) with atypical fracture

COUNTER MATCHED CONTROLS

Description:

Adults with current or past history of bisphosphonate treatment (exposed) without bisphosphonate related osteonecrosis of the jaws (BRONJ, or, Adults with current or past history of bisphosphonate treatment (exposed) with typical fracture or joint replacement or osteoporosis

MATCHED CONTROLS

Description:

Adults without current bisphosphonate treatment (unexposed) with Typical fracture (healthy fracture patients) Adults without current bisphosphonate treatment (unexposed) without BRONJ (healthy oral surgery subjects or adults with radionecrosis of the jaws)

Healthy Adult Volunteers

Description:

Healthy volunteers with or without current bisphosphonate treatment without jaw or extremity pathologies or injuries to contribute blood and saliva samples only.