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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

314 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-13

Study Completion Date

2022-10-30

Brief Summary

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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.

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Detailed Description

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

Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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CASES

Adults 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

No interventions assigned to this group

COUNTER MATCHED CONTROLS

Adults 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

No interventions assigned to this group

MATCHED CONTROLS

Adults 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)

No interventions assigned to this group

Healthy Adult Volunteers

Healthy volunteers with or without current bisphosphonate treatment without jaw or extremity pathologies or injuries to contribute blood and saliva samples only.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes