NCT03390777

Brief Summary

Medication related Osteonecrosis of the Jaw (MRONJ) consists of progressive destruction of bone in the maxillofacial area. It is an established complication which occurs in patients who take two main classes of antiresorptive drugs: Bisphosphonates (BP) and Denosumab. PRGF is a autologous platelet-enriched plasma obtained from the patient's own blood. It contains proteins that can influence and promote cell recruitment and its beneficial effect could consist in improving bone and soft tissue healing. These benefits are likely to apply to MRONJ surgery, as it is suggested by small retrospective or prospective case series. This is a randomized, multi center study comparing the outcomes of surgery alone and PRGF plus surgery in patients requiring surgical treatment for MRONJ. To assess the superiority of surgery plus PRGF compared to surgery alone in patients treated for MRONJ. Primary endpoint for this scope is a composite of clinical or radiological recurrence rate of disease during a 12 months post-operative period. Secondary endpoints are: a) morbidity, defined as nerve injury, bleeding, vascular or wound complications. b) post- and peri-operative pain defined by the treated subjects according to a standardized VAS score c) quality of life (QoL) defined by a standardized scale.

Trial Health

35
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 phase_2

Timeline
Completed

Started Sep 2018

Typical duration for phase_2

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 4, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

January 8, 2018

Status Verified

January 1, 2018

Enrollment Period

3 years

First QC Date

December 26, 2017

Last Update Submit

January 4, 2018

Conditions

Osteonecrosis Due to Drugs, Jaw

Outcome Measures

Primary Outcomes (1)

  • recurrence of disease

    clinical or radiological recurrence rate of disease during a 12 months post-operative period

    12 months

Secondary Outcomes (3)

  • morbidity

    12 months

  • post- and peri-operative pain

    1 week

  • quality of life (QoL)

    12 months

Study Arms (2)

surgery only

ACTIVE COMPARATOR

Surgery consisting in debridement/removal of affected tissue/s will be performed.

Procedure: surgery

surgery and PRGF

ACTIVE COMPARATOR

Surgery consisting in debridement/removal of affected tissue/s will be performed. Platelet Rich Growth Factor (device) will be produced by a venous blood sampling of the patient and applied to the treated area

Device: PRGF after surgery

Interventions

surgeryPROCEDURE

surgery without the use of prgf

surgery only
PRGF after surgeryDEVICE

surgery and application of PRGF

surgery and PRGF

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must be candidates for surgical treatment for MRONJ at stage 2 or 3.
  • Subjects must be \>18 and \<80 years of age
  • Subjects must sign a informed consent prior to randomization and must agree to return to scheduled follow-up visits

You may not qualify if:

  • Subject has inability to understand and cooperate with the study procedures or provide informed consent
  • Subject has bleeding diathesis or coaugolapthy, or will refuse autologous blood sampling
  • Subject had a cardiovascular event in the past 30 days
  • Subject has any condition that limits their anticipated survival to less than 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Beth-Tasdogan NH, Mayer B, Hussein H, Zolk O, Peter JU. Interventions for managing medication-related osteonecrosis of the jaw. Cochrane Database Syst Rev. 2022 Jul 12;7(7):CD012432. doi: 10.1002/14651858.CD012432.pub3.

    PMID: 35866376DERIVED

MeSH Terms

Interventions

Surgical Procedures, Operative

Central Study Contacts

Oreste Iocca, D.D.S., M.D.

CONTACT

0039 3398540122oi243@nyu.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS, MD

Study Record Dates

First Submitted

December 26, 2017

First Posted

January 4, 2018

Study Start

September 1, 2018

Primary Completion

September 1, 2021

Study Completion

January 1, 2022

Last Updated

January 8, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will share

IPD will be shared and evaluated upon requests

Shared Documents
STUDY PROTOCOL, SAP, CSR