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

Information source: University of Pennsylvania
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

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

Phase: N/A

Status: Recruiting

Sponsored by: University of Pennsylvania

Official(s) and/or principal investigator(s):
Samir Mehta, MD, Principal Investigator, Affiliation: University of Pennsylvania, Department of Orthopaedic Surgery
David C Stanton, MD, DMD, Principal Investigator, Affiliation: University of Pennsylvania, Department of Oral Surgery
Annamarie D Horan, PhD, Study Director, Affiliation: University of Pennsylvania

Overall contact:
Patrick Hesketh, BS, Phone: 781-985-3556, Email: patrick.hesketh@uphs.upenn.edu

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.

Clinical Details

Official title: Biomarker Identification in Orthopaedic and Oral Maxillofacial Subjects

Study design: Observational Model: Ecologic or Community, Time Perspective: Prospective

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

Secondary outcome: Differential expression of miRNA biomarkers across participant groups within the study

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Patrick Hesketh, BS, Phone: 781-985-3556, Email: patrick.hesketh@uphs.upenn.edu

Online participation via https://www.surveymonkey.com/s/bisphos4ctg, Philadelphia, Pennsylvania 19104, United States; Recruiting
Patrick Hesketh, Phone: 781-985-9556, Email: Patrick.Hesketh@uphs.upenn.edu

University of Pennsylvania Health System, Philadelphia, Pennsylvania 19104, United States; Recruiting
Patrick Hesketh, BS, Phone: 781-985-9556, Email: patrick.hesketh@uphs.upenn.edu
Annamarie D Horan, MPA, PhD, Phone: 215-349-8856, Email: horana@uphs.upenn.edu
Samir Mehta, MD, Principal Investigator
David C Stanton, MD, DMD, Principal Investigator

Additional Information

To participate in this study, and be taken to the Survey Monkey survey, click here.

Starting date: May 2013
Last updated: December 8, 2014

Page last updated: August 23, 2015

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