Clinical trial NCT01875458: Biomarker Identification in Orthopaedic & Oral Maxillofacial Surgery Subjects to Identify Risks of Bisphosphonate Use
Official title: Biomarker Identification in Orthopaedic and Oral Maxillofacial Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis, With or Without Treatment
Bisphosphonate Treatment
Atypical Femur Fracture
Bisphosphonate Related Osteonecrosis of the Jaws (BRONJ)
Healthy Volunteers
Keywords: Aclasta
Actonel
alendronate
alendronate/cholecalciferol
Aredia
Atelvia
Boniva
Didronel
etidronate
Fosamax
Fosamax Plus D
ibandronate
pamidronate
Reclast
risedronate
Skelid
tiludronate
zoledronic acid
Zometa
Bisphosphonate
Atypical Femur Fracture (AFF)
Osteoporosis
Bisphosphonate Related Osteonecrosis of the Jaw (BRONJ)
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2013-06-11
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults who either have ever taken bisphosphonates (see list under Key Words) and/or who have ever had an atypical femur fracture or bisphosphonate related osteonecrosis of the jaws (BRONJ) or both. Also healthy volunteers.

Brief 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.

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

Eligibility 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.

Primary outcomes:
measure: Absorption, Distribution, Metabolism, Excretion (ADME) Profiling of DNA from all sample types vs. normative data for the ADME panel and across study groups
timeFrame: Baseline
Secondary outcomes:
measure: Differential expression of miRNA biomarkers across participant groups within the study
timeFrame: Baseline
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania, Department of Orthopaedic Surgery
name: Samir Mehta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Annamarie D Horan, PhD
role: STUDY_DIRECTOR
References: