Performance Evaluation of the Micromedic BRONJ Risk Assessment in Vitro Diagnostic Assay

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-12-31

Brief Summary

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To evaluate the performance of the Micromedic BRONJ Risk Assessment in vitro assay (the "BRONJ Assay") in identifying Multiple Myeloma (MM) and/or other cancer subjects at risk for developing Bisphosphonate-related Osteonecrosis of the Jaw (BRONJ) following intravenous (IV) administration of Bisphosphonates (BP).

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Detailed Description

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The Micromedic BRONJ Assay is intended for the qualitative analysis of genetic changes which may be indicative of increased risk to develop BRONJ osteonecrosis of the jaw (ONJ) following IV administration of drugs of the Bisphosphonate family.

Conditions

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Bisphosphonate-related Osteonecrosis of the Jaw

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Study Group

Subject has been diagnosed with BRONJ

Group Type EXPERIMENTAL

BRONJ

Intervention Type GENETIC

collection of the blood sample from the subject for evaluation of the Micromedic BRONJ Risk Assessment in vitro Diagnostic Assay

Control Group

Subject has not developed any signs or symptoms of BRONJ

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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BRONJ

collection of the blood sample from the subject for evaluation of the Micromedic BRONJ Risk Assessment in vitro Diagnostic Assay

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

1. Subject is ≥18 years old
2. Subject is or was a Multiple Myeloma and/or other cancer patient who is or has been IV treated with the BP zoledronic acid and/or pamidronate disodium; Or; Subject is or was a Multiple Myeloma and/or other cancer patient who is or has been IV treated with the BP zoledronic acid and/or pamidronate disodium and was also treated by oral BP such as sodium alendronate, and in the opinion of the PI, IV treatment was significant enough to be considered as the cause for BRONJ
3. Subject has been diagnosed with BRONJ at stages 1 or 2 or 3 according to AAOMS (American Association of Oral and Maxillofacial Surgeons)
4. Subject has signed the informed consent or consent can be waived

1. Subject is ≥18 years old
2. Subject is or was a Multiple Myeloma and/or other cancer patient who is, or has been IV treated with the BP zoledronic acid and/or pamidronate disodium for at least two (2) years (continuously or cumulatively)
3. Subject has not developed any signs or symptoms of BRONJ
4. Subject has signed the informed consent or consent can be waived

Exclusion Criteria

1. Subject has been treated with irradiation to the jaws or head and neck at levels exceeding 35 Gy
2. Pregnant or lactating women
3. Subject has been treated with either bevacizumab or sunitimib
4. Subject has been treated with Allogeneic hematopoietic stem cell transplantation (HSCT)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No