Osteonecrosis of the JawNCT06457776
Medication Related Osteonecrosis of the Jaws (MRONJ) in a Cohort of Patients Treated by Antiresorptive Drugs
An observational study of Osteonecrosis of the Jaw and Osteonecrosis Due to Drugs, Jaw, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
The objective of this prospective observational study is to investigate the incidence of Medication Related Osteonecrosis of the Jaws (MRONJ) in patients receiving antiresorptive drugs for oncohematologic reasons during a 5-year follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteonecrosis of the Jaw, Osteonecrosis Due to Drugs, Jaw, Osteonecrosis Due to Drug
- What is being tested?
- Dental management
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 126 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2021to 1 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients starting an antiresorptive drug
Who may be able to join
- Patients with specific prescription to initiate therapy with antiresorptive drugs
Who cannot join
- Previous Head and Neck Radiotherapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Medication Related Osteonecrosis of the Jaws (MRONJ) in a Cohort of Patients Treated by Antiresorptive Drugs: a Cohort Prospective Study
The objective of this prospective observational study is to investigate the incidence of Medication Related Osteonecrosis of the Jaws (MRONJ) in patients receiving antiresorptive drugs for oncohematologic reasons during a 5-year follow-up. Secondary objectives are to compare the different antiresorptive drugs in relation to the incidence of MRONJ and to identify any systemic as well as local risk factors.
Read the detailed description
Antiresorptive drugs are widely used for the prevention and treatment of numerous diseases involving the skeletal system. In particular, they have been shown to be effective in reducing the incidence of skeletal events in oncohematologic patients.
Specifically, bone represents a highly affected site of metastatic cancer (i.e., bone metastases from solid tumors of various origins--breast, prostate, renal; multiple myeloma). In the United States, approximately 400,000 individuals suffer from bone metastasis. The most frequent skeletal complications in patients with bone metastases (referred to as SRE - skeletal-related events - in the international literature) include pathologic fractures, spinal cord compression, malignant hypercalcemia, and the need to undergo radiation therapy or surgery on the bone lesion.The introduction of anti-bone resorption drugs (bisphosphonates and denosumab) has reduced the rate of skeletal complications by 30-50% so they are indicated in the management of the oncohematology patient.
The objective of this prospective observational study is to investigate the incidence of Medication Related Osteonecrosis of the Jaws (MRONJ) in patients receiving antiresorptive drugs for oncohematologic reasons during a 5-year follow-up. Secondary objectives are to compare the different antiresorptive drugs in relation to the incidence of MRONJ and to identify any systemic as well as local risk factors.
- Conditions
- Osteonecrosis of the Jaw, Osteonecrosis Due to Drugs, Jaw, Osteonecrosis Due to Drug, Bisphosphonate-Associated Osteonecrosis, Bisphosphonate-Associated Osteonecrosis of the Jaw
- Being tested
- Dental management
- 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.
Dental managementProcedure or surgery
The oral conditions of the included patients will be evaluated at baseline. When indicated, dental extractions will be performed before the beginning of Antiresorptive Therapy. Patients will then receive a six-months intervals follow-up, during which primary and secondary prevention of dental diseases will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Antiresorptive Drugs | Patients treated by means of Antiresorptive drugs due to either bone metastasis or metabolic diseases Receives: Procedure: Dental management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Related OsteoNecrosis of the Jaws
Incidence of Medication Related OsteoNecrosis of the Jaws
Measured: Five years after the beginning of AR therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Jan 2021
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2028 (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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Lajolo, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457776
- Sponsor's protocol ID
- MRONJ-1
- Status last verified
- Jun 2024
- First submitted
- 8 Jun 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rupe C, Gioco G, Tranfa M, Scilla F, Schiavelli A, Cairo F, Galli J, Scambia G, Rengo C, Lajolo C. Differences in oral health status between cancer patients: a case-control observational study. BMC Oral Health. 2025 Dec 1;25(1):1862. doi: 10.1186/s12903-025-06963-7.
PubMed 41327109
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Related Osteonecrosis of the Jaws (MRONJ) in a Cohort of Patients Treated by Antiresorptive Drugs: a Cohort Prospective Study
- ClinicalTrials.gov ID
- NCT06457776
- Acronym / sponsor ID
- MRONJ-1
- Conditions
- Osteonecrosis of the Jaw, Osteonecrosis Due to Drugs, Jaw, Osteonecrosis Due to Drug, Bisphosphonate-Associated Osteonecrosis, Bisphosphonate-Associated Osteonecrosis of the Jaw
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 13 Jun 2024 (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.
The objective of this prospective observational study is to investigate the incidence of Medication Related Osteonecrosis of the Jaws (MRONJ) in patients receiving antiresorptive drugs for oncohematologic reasons during a 5-year follow-up. Secondary objectives are to compare the different antiresorptive drugs in relation to the incidence of MRONJ and to identify any systemic as well as local risk factors.
Detailed description
Antiresorptive drugs are widely used for the prevention and treatment of numerous diseases involving the skeletal system. In particular, they have been shown to be effective in reducing the incidence of skeletal events in oncohematologic patients.
Specifically, bone represents a highly affected site of metastatic cancer (i.e., bone metastases from solid tumors of various origins--breast, prostate, renal; multiple myeloma). In the United States, approximately 400,000 individuals suffer from bone metastasis. The most frequent skeletal complications in patients with bone metastases (referred to as SRE - skeletal-related events - in the international literature) include pathologic fractures, spinal cord compression, malignant hypercalcemia, and the need to undergo radiation therapy or surgery on the bone lesion.The introduction of anti-bone resorption drugs (bisphosphonates and denosumab) has reduced the rate of skeletal complications by 30-50% so they are indicated in the management of the oncohematology patient.
The objective of this prospective observational study is to investigate the incidence of Medication Related Osteonecrosis of the Jaws (MRONJ) in patients receiving antiresorptive drugs for oncohematologic reasons during a 5-year follow-up. Secondary objectives are to compare the different antiresorptive drugs in relation to the incidence of MRONJ and to identify any systemic as well as local risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antiresorptive Drugs | – | Procedure: Dental managementPatients treated by means of Antiresorptive drugs due to either bone metastasis or metabolic diseases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients starting an antiresorptive drug
Key inclusion criteria (1 listed)
- Patients with specific prescription to initiate therapy with antiresorptive drugs
Key exclusion criteria (1 listed)
- Previous Head and Neck Radiotherapy
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 |
|---|---|---|
| Dental managementThe oral conditions of the included patients will be evaluated at baseline. When indicated, dental extractions will be performed before the beginning of Antiresorptive Therapy. Patients will then receive a six-months intervals follow-up, during which primary and secondary prevention of dental diseases will be performed. | Procedure or surgery | Antiresorptive Drugs |
Primary outcome
Medication Related OsteoNecrosis of the Jaws
Time frame: Five years after the beginning of AR therapy
Incidence of Medication Related OsteoNecrosis of the Jaws
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Derived from this study: PubMed 41327109Rupe C, Gioco G, Tranfa M, Scilla F, Schiavelli A, Cairo F, Galli J, Scambia G, Rengo C, Lajolo C. Differences in oral health status between cancer patients: a case-control observational study. BMC Oral Health. 2025 Dec 1;25(1):1862. doi: 10.1186/s12903-025-06963-7.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteonecrosis of the Jaw and Osteonecrosis Due to Drugs, Jaw, run by Catholic University of the Sacred Heart at 1 site in Italy.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carlo Lajolo, Prof. (3356078354 ext. +39, carlo.lajolo@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Related OsteoNecrosis of the Jaws (time frame: Five years after the beginning of AR therapy). 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 NCT06457776, 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 20 Jun 2024.