Bisphosphonate-related Osteonecrosis of the JawBRONJNCT02218554
Performance Evaluation of the Micromedic BRONJ Risk Assessment in Vitro Diagnostic Assay
A study testing BRONJ in people with Bisphosphonate-related Osteonecrosis of the Jaw, run by Micromedic Technologies Ltd at 2 sites in Israel.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bisphosphonate-related Osteonecrosis of the Jaw
- What is being tested?
- BRONJ
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesIsrael
- Study dates
- Jan 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is ≥18 years old
- 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
- Subject has been diagnosed with BRONJ at stages 1 or 2 or 3 according to AAOMS (American Association of Oral and Maxillofacial Surgeons)
- Subject has signed the informed consent or consent can be waived
- Subject is ≥18 years old
- 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)
- Subject has not developed any signs or symptoms of BRONJ
- Subject has signed the informed consent or consent can be waived
Who cannot join
- Subject has been treated with irradiation to the jaws or head and neck at levels exceeding 35 Gy
- Pregnant or lactating women
- Subject has been treated with either bevacizumab or sunitimib
- Subject has been treated with Allogeneic hematopoietic stem cell transplantation (HSCT)
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
Sheba Medical Center
Tel HaShomer
Noam Yarom, Dr.
Noam Yarom, Dr
- Recruiting
Sheba Medical Center
Tel HaShomer
Noam Yarom, Dr
About this study
Official title: Performance Evaluation of the Micromedic BRONJ Risk Assessment in Vitro Diagnostic Assay.
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).
Read the 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.
- Being tested
- BRONJ
- Keywords
- BRONJ
- Medical subject headings
- Bisphosphonate-Associated Osteonecrosis of the Jaw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRONJGenetic
collection of the blood sample from the subject for evaluation of the Micromedic BRONJ Risk Assessment in vitro Diagnostic Assay
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Subject has been diagnosed with BRONJ Receives: Genetic: BRONJ |
| Control Group | No intervention | Subject has not developed any signs or symptoms of BRONJ |
What is being measured
The primary outcome is the main question the study is designed to answer.
For each subject, the primary endpoint is the presence or absence of SNPs or other genetic alterations obtained from the assay for blood samples
Measured: up to 2 years
Secondary outcomes (1)
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
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startJan 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bisphosphonate-related Osteonecrosis of the JawStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Micromedic Technologies Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Noam Yarom, Dr., Principal investigator, Sheba MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02218554
- Sponsor's protocol ID
- CL-BNJ-001-PR
- Acronym
- BRONJ
- Status last verified
- May 2014
- First submitted
- 13 Aug 2014
- Last updated
- 18 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation of the Micromedic BRONJ Risk Assessment in Vitro Diagnostic Assay.
- ClinicalTrials.gov ID
- NCT02218554
- Acronym / sponsor ID
- BRONJ / CL-BNJ-001-PR
- Keywords
- BRONJ
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Micromedic Technologies LtdIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 18 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Genetic: BRONJSubject has been diagnosed with BRONJ |
| Control Group | No intervention | –Subject has not developed any signs or symptoms of BRONJ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is ≥18 years old
- 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
- Subject has been diagnosed with BRONJ at stages 1 or 2 or 3 according to AAOMS (American Association of Oral and Maxillofacial Surgeons)
- Subject has signed the informed consent or consent can be waived
- Subject is ≥18 years old
Key exclusion criteria (4 listed)
- Subject has been treated with irradiation to the jaws or head and neck at levels exceeding 35 Gy
- Pregnant or lactating women
- Subject has been treated with either bevacizumab or sunitimib
- Subject has been treated with Allogeneic hematopoietic stem cell transplantation (HSCT)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BRONJcollection of the blood sample from the subject for evaluation of the Micromedic BRONJ Risk Assessment in vitro Diagnostic Assay | Genetic | Study Group |
Primary outcome
For each subject, the primary endpoint is the presence or absence of SNPs or other genetic alterations obtained from the assay for blood samples
Time frame: up to 2 years
1 secondary outcome
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
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noam Yarom, Dr. principal investigator
Sheba MC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BRONJ in people with Bisphosphonate-related Osteonecrosis of the Jaw, run by Micromedic Technologies Ltd at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noam Yarom, Dr. (972-35303819, noamyar@post.tau.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
For each subject, the primary endpoint is the presence or absence of SNPs or other genetic alterations obtained from the assay for blood samples (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2014.