Biomarker Identification in Orthopaedic & Oral Maxillofacial Surgery Subjects to Identify Risks of Bisphosphonate Use
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies, Osteoporosis, Orthopedic |
| Therapuetic Areas: | Rheumatology, Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/13/2018 |
| Start Date: | May 2013 |
| End Date: | April 2028 |
| Contact: | Brandon Eilberg, BS |
| Email: | brandon.eilberg@uphs.upenn.edu |
| Phone: | 215-294-9167 |
Biomarker Identification in Orthopaedic and Oral Maxillofacial Subjects
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.
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.
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.
We found this trial at
2
sites
Philadelphia, Pennsylvania 19104
Phone: 781-985-9556
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Philadelphia, Pennsylvania 19104
Principal Investigator: Samir Mehta, MD
Phone: 215-291-9167
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