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

NCT01875458 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 314

Last updated 2023-01-13

No results posted yet for this 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.

Conditions

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

Sponsors & Collaborators

Principal Investigators

  • Samir Mehta, MD · University of Pennsylvania, Department of Orthopaedic Surgery

  • Annamarie D Horan, PhD · University of Pennsylvania

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-13
Primary Completion
2022-10-30
Completion
2022-10-30

Countries

  • United States

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01875458 on ClinicalTrials.gov