NCT02218554

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 18, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 18, 2014

Status Verified

May 1, 2014

Enrollment Period

2.9 years

First QC Date

August 13, 2014

Last Update Submit

August 14, 2014

Conditions

Bisphosphonate-related Osteonecrosis of the Jaw

Keywords

BRONJ

Outcome Measures

Primary Outcomes (1)

  • 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 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

    up to 2 years

Other Outcomes (1)

  • Safety endpoints will include adverse events (AEs), including serious AEs (SAEs) whether or not deemed related to study procedures

    2 years

Study Arms (2)

Study Group

EXPERIMENTAL

Subject has been diagnosed with BRONJ

Genetic: BRONJ

Control Group

NO INTERVENTION

Subject has not developed any signs or symptoms of BRONJ

Interventions

BRONJGENETIC

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

Study Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sheba Medical Center

Tel Litwinsky, Israel

RECRUITING

Sheba Medical Center

Tel Litwinsky, Israel

RECRUITING

MeSH Terms

Conditions

Bisphosphonate-Associated Osteonecrosis of the Jaw

Condition Hierarchy (Ancestors)

OsteonecrosisBone DiseasesMusculoskeletal DiseasesJaw DiseasesStomatognathic DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Noam Yarom, Dr.

    Sheba MC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Noam Yarom, Dr.

CONTACT

972-35303819noamyar@post.tau.ac.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2014

First Posted

August 18, 2014

Study Start

January 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

August 18, 2014

Record last verified: 2014-05

Locations

IL(2)