Osteoporosis, With or Without Treatment |
Osteoporosis, With or Without Treatment research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Osteoporosis, With or Without Treatment
Atypical Femur Fracture
Bisphosphonate Related Osteonecrosis of the Jaws (BRONJ)
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
CASESAdults 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 CONTROLSAdults 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 CONTROLSAdults 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 VolunteersHealthy volunteers with or without current bisphosphonate treatment without jaw or extremity pathologies or injuries to contribute blood and saliva samples only.
Start Date: May 2013
Completed Date: April 2018
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
Study sponsors, principal investigator, and references
Principal Investigator: Samir Mehta, MD
Lead Sponsor: University of Pennsylvania