Bisphosphonate-related Osteonecrosis of the Jaw
Conditions
Keywords
BRONJ
Brief summary
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).
Detailed description
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.
Interventions
GENETICBRONJ
collection of the blood sample from the subject for evaluation of the Micromedic BRONJ Risk Assessment in vitro Diagnostic Assay
Sponsors
Micromedic Technologies Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria Study Group (all of the following): 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 Inclusion Criteria Control Group (all of the following): 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For each subject, the primary endpoint is the presence or absence of SNPs or other genetic alterations obtained from the assay for blood samples | up to 2 years |
Secondary
| Measure | Time frame |
|---|---|
| For each subject, the secondary endpoint is the presence or absence of additional/alternative SNPs or other genetic alterations using GWAS analysis and/or Full Exome Sequencing (FES) from the assay for blood samples | up to 2 years |
Other
| Measure | Time frame |
|---|---|
| Safety endpoints will include adverse events (AEs), including serious AEs (SAEs) whether or not deemed related to study procedures | 2 years |
Countries
Israel
Contacts
Primary ContactNoam Yarom, Dr.
Outcome results
None listed