Osteonecrosis Due to Drugs, JawPhase 2/3NCT03390777
Plasma Rich in Growth Factors for Treatment of Medication Related Osteonecrosis of the Jaw
A Phase 2/3 study testing surgery and PRGF after surgery in people with Osteonecrosis Due to Drugs, Jaw, run by University of Roma La Sapienza.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteonecrosis Due to Drugs, Jaw
- What is being tested?
- surgery and PRGF after surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Sep 2018to Jan 2022
- Phase
- Phase 2/3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Plasma Rich in Growth Factors for Treatment of Medication Related Osteonecrosis of the Jaw: a Multicenter, Randomized, Clinical Trial
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.
Read more
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.
- Conditions
- Osteonecrosis Due to Drugs, Jaw
- Being tested
- surgery, PRGF after surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryProcedure or surgery
surgery without the use of prgf
PRGF after surgeryDevice
surgery and application of PRGF
| Study group | Role | What they receive |
|---|---|---|
| surgery only | Active comparator | Surgery consisting in debridement/removal of affected tissue/s will be performed. Receives: 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 Receives: Device: PRGF after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence of disease
clinical or radiological recurrence rate of disease during a 12 months post-operative period
Measured: 12 months
Secondary outcomes (3)
morbidity
nerve injury, bleeding, vascular or wound complications
Measured: 12 months
post- and peri-operative pain
defined by the treated subjects according to a standardized Visual Analog Scale (VAS) score which will be used to define the pain in this way: the patient will assign a value to the experienced pain that goes from 0 no pain to 10 the worst pain the patient can imagine.
Measured: 1 week
quality of life (QoL)
defined by a standardized scale developed by the who and whose details can be on the who website http://www.who.int/mental_health/publications/whoqol/en/
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study startSep 2018 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteonecrosis Due to Drugs, JawStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Collaborators
- NYU College of Dentistry, Universidade da Coruña
- Responsible party
- Principal investigator, Oreste Iocca, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390777
- Sponsor's protocol ID
- 26122017
- Status last verified
- Jan 2018
- First submitted
- 26 Dec 2017
- Last updated
- 8 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared and evaluated upon requests
Publications
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.
PubMed 35866376
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Rich in Growth Factors for Treatment of Medication Related Osteonecrosis of the Jaw: a Multicenter, Randomized, Clinical Trial
- ClinicalTrials.gov ID
- NCT03390777
- Acronym / sponsor ID
- 26122017
- Conditions
- Osteonecrosis Due to Drugs, Jaw
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Collaborators
- NYU College of Dentistry, Universidade da Coruña
- Study start
- Sep 2018 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 4 Jan 2018 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgery only | Active comparator | Procedure: surgerySurgery consisting in debridement/removal of affected tissue/s will be performed. |
| surgery and PRGF | Active comparator | Device: PRGF after surgerySurgery 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| surgerysurgery without the use of prgf | Procedure or surgery | surgery only |
| PRGF after surgerysurgery and application of PRGF | Device | surgery and PRGF |
Primary outcome
recurrence of disease
Time frame: 12 months
clinical or radiological recurrence rate of disease during a 12 months post-operative period
3 secondary outcomes
morbidity
Time frame: 12 months
post- and peri-operative pain
Time frame: 1 week
quality of life (QoL)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2018.
- Derived from this study: PubMed 35866376Beth-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.
- Individual participant dataSharing planned: Yes. IPD will be shared and evaluated upon requests
Related trials for Osteonecrosis Due to Drugs, Jaw
Not yet recruiting
Piezoeletric Surgery vs Conventional Surgery for Treatment of MRONJ
Bisphosphonate-Associated Osteonecrosis of the Jaw, Osteonecrosis of the Jaw
RecruitingObservational study
Medication Related Osteonecrosis of the Jaws (MRONJ) in a Cohort of Patients Treated by Antiresorptive Drugs
Osteonecrosis of the Jaw, Osteonecrosis Due to Drugs, Jaw
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing surgery and PRGF after surgery in people with Osteonecrosis Due to Drugs, Jaw, run by University of Roma La Sapienza.
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 3 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 8 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Oreste Iocca, D.D.S., M.D. (0039 3398540122, oi243@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence of disease (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03390777, which also lists 1 linked publication.
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 8 Jan 2018.