Osteonecrosis Due to Drugs, JawPREV-ONMNCT04257721
Predictive Score For Maxillary Osteonecrosis After Invasive Oral Surgery
An observational study of Osteonecrosis Due to Drugs, Jaw, run by Centre Hospitalier Sud Francilien at 5 sites in France.
Trial summary
Non-interventional prospective multicentre cohort study to determine a predictive score for the occurrence of osteochimionecrosis of the jaws after invasive oral surgery in patients who have received biphosphonates or antangiogenic drugs as part of chemotherapy with malignant bone disease (multiple myeloma or bone… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteonecrosis Due to Drugs, Jaw
- How many people
- 45 participants
- Where
- 5 sitesFrance
- Study dates
- 10 Oct 2019to 6 Apr 2022
- Phase
- Observational
- 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
Study population: patients who have received biphosphonates or antangiogenic drugs as part of chemotherapy with malignant bone disease (multiple myeloma or bone metastasis of a solid tumour) and who has had an oral surgical procedure (single or multiple dental extraction, with or without alveolectomy, under local or general anesthesia)
Who may be able to join
- patients who have received at least one of the following molecules as part of chemotherapy with malignant bone disease (multiple myeloma or bone metastasis of a solid tumour):
- Biphosphonates: ZOLEDRONATE (ZOMETA®), PAMIDRONATE (AREDIA®, OSTEPAM®)
- Anti-angiogenic: DENOSUMAB (XGEVA®), BEVACIZUMAB (AVASTIN®), RITUXIMAB (MABTHERA®, RIXATHON®, TRUXIMA®), SUNITINIB (SUTENT®), PAZOPANIB (VOTRIENT®), AXITINIB (INLYTA®), CARBOZANTINIB (CABOMETYX®, COMETRIQ®), SORAFENIB (NEXAVAR®)
- Patient who has had an oral surgical procedure (single or multiple dental extraction, with or without alveolectomy, under local or general anesthesia)
Who cannot join
- History of oral and/or cervico-facial radiotherapy
- Patient treated successively with biphosphonates and then with anti-angiogenic drugs.
- Patient under guardianship, curatorship, or imprisonment
- Patient who has notified his refusal to participate in the research
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Centre Hospitalier Intercommunal Robert Ballanger
Aulnay-sous-Bois, 93600
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91106
Centre Hospitalier Universitaire Henri Mondor
Créteil, 94010
Centre Hospitalier Bretagne Atlantique
Vannes, 56017
Institut Gustave Roussy
Villejuif, 94805
About this study
Official title: Development Of A Predictive Score For Maxillary Osteochimionecrosis After Invasive Oral Surgery In Patients Treated Whith Biphosphonates Or Biotherapies: The PREV-ONM Study
Non-interventional prospective multicentre cohort study to determine a predictive score for the occurrence of osteochimionecrosis of the jaws after invasive oral surgery in patients who have received biphosphonates or antangiogenic drugs as part of chemotherapy with malignant bone disease (multiple myeloma or bone metastasis of a solid tumour).
Data are collected during the usual follow-up of patients during the first 3 months following surgery.
Read the detailed description
Non-interventional prospective multicentre cohort study to determine a predictive score for the occurrence of osteochimionecrosis of the jaws after invasive oral surgery in patients who have received at least one of the following molecules as part of chemotherapy with malignant bone disease (multiple myeloma or bone metastasis of a solid tumour):
- Biphosphonates: ZOLEDRONATE (ZOMETA®), PAMIDRONATE (AREDIA®, OSTEPAM®)
- Anti-angiogenic: DENOSUMAB (XGEVA®), BEVACIZUMAB (AVASTIN®), RITUXIMAB (MABTHERA®, RIXATHON®, TRUXIMA®), SUNITINIB (SUTENT®), PAZOPANIB (VOTRIENT®), AXITINIB (INLYTA®), CARBOZANTINIB (CABOMETYX®, COMETRIQ®), SORAFENIB (NEXAVAR®)
The study protocol is based on the post-operative clinical and radiographic follow-up of patients. 3 consultations are scheduled:
- 1 week after surgery
- 1 month after surgery
- 3 months after surgery
The following information should be noted at each follow-up consultation:
- Appearance of gingival and mucosal tissues : normal or inflammatory physiological state
- Description of possible bone exposure: size, colour, spontaneous or induced bleeding
- Description and assessment of local pain
- Description of a local infection
- Results of a bacteriological sample in case of suppuration
The patient's participation in the study ends:
- at the end of one of the consultations at 1 week and 1 month as soon as osteochimionecrosis of the jaws is diagnosed by the investigating physician
- at the end of the consultation at 3 months otherwise
- in the event of the patient's death during the study
- in the event of the patient's renouncement to participate in the study The patient's participation period is therefore a maximum of 3 months.
- Conditions
- Osteonecrosis Due to Drugs, Jaw
- Keywords
- jaw osteonecrosis, biphosphonates, antiangiogenic agents, oral surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of osteonecrosis of the jaw
occurrence of osteonecrosis of the jaw
Measured: within 3 months after surgery
Secondary outcomes (1)
Frequency of post-operative healing (bone and gingival) and comparison to each patient's UCONNS score.
Frequency of post-operative healing (bone and gingival) and comparison to each patient's UCONNS score.
The UCONNS score was proposed in 2011. Its objective is to be able to predict the occurrence of osteochimionecrosis in conjunction with biphosphonate treatment before a dental invasive procedure (dental avulsions, implant placement, etc.). It takes into account several types of variables:
- The patient's general condition and comorbidities (HIV, osteoporosis, rheumatoid arthritis, diabetes, presence or not of a soft tissue tumour, presence or not of a breast or prostate tumour, multiple myeloma, ...)
- The nature, dose, and duration of use of the biphosphonate received
- Oral hygiene
- presence of suppuration, presence of osteomyelitis
- The dental surgery received (endodontic treatment, periodontal treatment, surgery muco-gingival, tooth extraction, apical surgery, bone resection)
Measured: within 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start10 Oct 2019
- Primary completion6 Apr 2022
- Study completion6 Apr 2022
Why it stopped: rate of inclusions too low
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Osteonecrosis Due to Drugs, 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emeline Noaillon, MD, Principal investigator, Centre Hospitalier Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257721
- Sponsor's protocol ID
- 2019-A01495-52
- Acronym
- PREV-ONM
- Status last verified
- Nov 2024
- First submitted
- 4 Feb 2020
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marx RE. Pamidronate (Aredia) and zoledronate (Zometa) induced avascular necrosis of the jaws: a growing epidemic. J Oral Maxillofac Surg. 2003 Sep;61(9):1115-7. doi: 10.1016/s0278-2391(03)00720-1. No abstract available.
PubMed 12966493Advisory Task Force on Bisphosphonate-Related Ostenonecrosis of the Jaws, American Association of Oral and Maxillofacial Surgeons. American Association of Oral and Maxillofacial Surgeons position paper on bisphosphonate-related osteonecrosis of the jaws. J Oral Maxillofac Surg. 2007 Mar;65(3):369-76. doi: 10.1016/j.joms.2006.11.003. No abstract available.
PubMed 17307580Ruggiero SL, Dodson TB, Fantasia J, Goodday R, Aghaloo T, Mehrotra B, O'Ryan F; American Association of Oral and Maxillofacial Surgeons. American Association of Oral and Maxillofacial Surgeons position paper on medication-related osteonecrosis of the jaw--2014 update. J Oral Maxillofac Surg. 2014 Oct;72(10):1938-56. doi: 10.1016/j.joms.2014.04.031. Epub 2014 May 5.
PubMed 25234529Qi WX, Tang LN, He AN, Yao Y, Shen Z. Risk of osteonecrosis of the jaw in cancer patients receiving denosumab: a meta-analysis of seven randomized controlled trials. Int J Clin Oncol. 2014 Apr;19(2):403-10. doi: 10.1007/s10147-013-0561-6. Epub 2013 Apr 20.
PubMed 23605142Allen MR, Burr DB. The pathogenesis of bisphosphonate-related osteonecrosis of the jaw: so many hypotheses, so few data. J Oral Maxillofac Surg. 2009 May;67(5 Suppl):61-70. doi: 10.1016/j.joms.2009.01.007.
PubMed 19371816Gaudin E, Seidel L, Bacevic M, Rompen E, Lambert F. Occurrence and risk indicators of medication-related osteonecrosis of the jaw after dental extraction: a systematic review and meta-analysis. J Clin Periodontol. 2015 Oct;42(10):922-32. doi: 10.1111/jcpe.12455. Epub 2015 Nov 3.
PubMed 26362756Peddi P, Lopez-Olivo MA, Pratt GF, Suarez-Almazor ME. Denosumab in patients with cancer and skeletal metastases: a systematic review and meta-analysis. Cancer Treat Rev. 2013 Feb;39(1):97-104. doi: 10.1016/j.ctrv.2012.07.002. Epub 2012 Aug 13.
PubMed 22898302Landesberg R, Woo V, Cremers S, Cozin M, Marolt D, Vunjak-Novakovic G, Kousteni S, Raghavan S. Potential pathophysiological mechanisms in osteonecrosis of the jaw. Ann N Y Acad Sci. 2011 Feb;1218:62-79. doi: 10.1111/j.1749-6632.2010.05835.x.
PubMed 21291478Reich W, Bilkenroth U, Schubert J, Wickenhauser C, Eckert AW. Surgical treatment of bisphosphonate-associated osteonecrosis: Prognostic score and long-term results. J Craniomaxillofac Surg. 2015 Nov;43(9):1809-22. doi: 10.1016/j.jcms.2015.07.035. Epub 2015 Aug 6.
PubMed 26321065
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development Of A Predictive Score For Maxillary Osteochimionecrosis After Invasive Oral Surgery In Patients Treated Whith Biphosphonates Or Biotherapies: The PREV-ONM Study
- ClinicalTrials.gov ID
- NCT04257721
- Acronym / sponsor ID
- PREV-ONM / 2019-A01495-52
- Conditions
- Osteonecrosis Due to Drugs, Jaw
- Keywords
- jaw osteonecrosis, biphosphonates, antiangiogenic agents, oral surgery
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: rate of inclusions too low
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 6 Apr 2022 (actual)
- Study completion
- 6 Apr 2022 (actual)
- First posted
- 6 Feb 2020 (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.
Non-interventional prospective multicentre cohort study to determine a predictive score for the occurrence of osteochimionecrosis of the jaws after invasive oral surgery in patients who have received biphosphonates or antangiogenic drugs as part of chemotherapy with malignant bone disease (multiple myeloma or bone metastasis of a solid tumour).
Data are collected during the usual follow-up of patients during the first 3 months following surgery.
Detailed description
Non-interventional prospective multicentre cohort study to determine a predictive score for the occurrence of osteochimionecrosis of the jaws after invasive oral surgery in patients who have received at least one of the following molecules as part of chemotherapy with malignant bone disease (multiple myeloma or bone metastasis of a solid tumour):
- Biphosphonates: ZOLEDRONATE (ZOMETA®), PAMIDRONATE (AREDIA®, OSTEPAM®)
- Anti-angiogenic: DENOSUMAB (XGEVA®), BEVACIZUMAB (AVASTIN®), RITUXIMAB (MABTHERA®, RIXATHON®, TRUXIMA®), SUNITINIB (SUTENT®), PAZOPANIB (VOTRIENT®), AXITINIB (INLYTA®), CARBOZANTINIB (CABOMETYX®, COMETRIQ®), SORAFENIB (NEXAVAR®)
The study protocol is based on the post-operative clinical and radiographic follow-up of patients. 3 consultations are scheduled:
- 1 week after surgery
- 1 month after surgery
- 3 months after surgery
The following information should be noted at each follow-up consultation:
- Appearance of gingival and mucosal tissues : normal or inflammatory physiological state
- Description of possible bone exposure: size, colour, spontaneous or induced bleeding
- Description and assessment of local pain
- Description of a local infection
- Results of a bacteriological sample in case of suppuration
The patient's participation in the study ends:
- at the end of one of the consultations at 1 week and 1 month as soon as osteochimionecrosis of the jaws is diagnosed by the investigating physician
- at the end of the consultation at 3 months otherwise
- in the event of the patient's death during the study
- in the event of the patient's renouncement to participate in the study The patient's participation period is therefore a maximum of 3 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who have received biphosphonates or antangiogenic drugs as part of chemotherapy with malignant bone disease (multiple myeloma or bone metastasis of a solid tumour) and who has had an oral surgical procedure (single or multiple dental extraction, with or without alveolectomy, under local or general anesthesia)
Key inclusion criteria (4 listed)
- patients who have received at least one of the following molecules as part of chemotherapy with malignant bone disease (multiple myeloma or bone metastasis of a solid tumour):
- Biphosphonates: ZOLEDRONATE (ZOMETA®), PAMIDRONATE (AREDIA®, OSTEPAM®)
- Anti-angiogenic: DENOSUMAB (XGEVA®), BEVACIZUMAB (AVASTIN®), RITUXIMAB (MABTHERA®, RIXATHON®, TRUXIMA®), SUNITINIB (SUTENT®), PAZOPANIB (VOTRIENT®), AXITINIB (INLYTA®), CARBOZANTINIB (CABOMETYX®, COMETRIQ®), SORAFENIB (NEXAVAR®)
- Patient who has had an oral surgical procedure (single or multiple dental extraction, with or without alveolectomy, under local or general anesthesia)
Key exclusion criteria (4 listed)
- History of oral and/or cervico-facial radiotherapy
- Patient treated successively with biphosphonates and then with anti-angiogenic drugs.
- Patient under guardianship, curatorship, or imprisonment
- Patient who has notified his refusal to participate in the research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
occurrence of osteonecrosis of the jaw
Time frame: within 3 months after surgery
occurrence of osteonecrosis of the jaw
1 secondary outcome
Frequency of post-operative healing (bone and gingival) and comparison to each patient's UCONNS score.
Time frame: within 3 months after surgery
Results and safety
The study was stopped early (reason given: rate of inclusions too low). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Results publication: PubMed 12966493Marx RE. Pamidronate (Aredia) and zoledronate (Zometa) induced avascular necrosis of the jaws: a growing epidemic. J Oral Maxillofac Surg. 2003 Sep;61(9):1115-7. doi: 10.1016/s0278-2391(03)00720-1. No abstract available.
- Results publication: PubMed 17307580Advisory Task Force on Bisphosphonate-Related Ostenonecrosis of the Jaws, American Association of Oral and Maxillofacial Surgeons. American Association of Oral and Maxillofacial Surgeons position paper on bisphosphonate-related osteonecrosis of the jaws. J Oral Maxillofac Surg. 2007 Mar;65(3):369-76. doi: 10.1016/j.joms.2006.11.003. No abstract available.
- Results publication: PubMed 25234529Ruggiero SL, Dodson TB, Fantasia J, Goodday R, Aghaloo T, Mehrotra B, O'Ryan F; American Association of Oral and Maxillofacial Surgeons. American Association of Oral and Maxillofacial Surgeons position paper on medication-related osteonecrosis of the jaw--2014 update. J Oral Maxillofac Surg. 2014 Oct;72(10):1938-56. doi: 10.1016/j.joms.2014.04.031. Epub 2014 May 5.
- Results publication: PubMed 23605142Qi WX, Tang LN, He AN, Yao Y, Shen Z. Risk of osteonecrosis of the jaw in cancer patients receiving denosumab: a meta-analysis of seven randomized controlled trials. Int J Clin Oncol. 2014 Apr;19(2):403-10. doi: 10.1007/s10147-013-0561-6. Epub 2013 Apr 20.
- Results publication: PubMed 19371816Allen MR, Burr DB. The pathogenesis of bisphosphonate-related osteonecrosis of the jaw: so many hypotheses, so few data. J Oral Maxillofac Surg. 2009 May;67(5 Suppl):61-70. doi: 10.1016/j.joms.2009.01.007.
- Results publication: PubMed 26362756Gaudin E, Seidel L, Bacevic M, Rompen E, Lambert F. Occurrence and risk indicators of medication-related osteonecrosis of the jaw after dental extraction: a systematic review and meta-analysis. J Clin Periodontol. 2015 Oct;42(10):922-32. doi: 10.1111/jcpe.12455. Epub 2015 Nov 3.
- Results publication: PubMed 22898302Peddi P, Lopez-Olivo MA, Pratt GF, Suarez-Almazor ME. Denosumab in patients with cancer and skeletal metastases: a systematic review and meta-analysis. Cancer Treat Rev. 2013 Feb;39(1):97-104. doi: 10.1016/j.ctrv.2012.07.002. Epub 2012 Aug 13.
- Results publication: PubMed 21291478Landesberg R, Woo V, Cremers S, Cozin M, Marolt D, Vunjak-Novakovic G, Kousteni S, Raghavan S. Potential pathophysiological mechanisms in osteonecrosis of the jaw. Ann N Y Acad Sci. 2011 Feb;1218:62-79. doi: 10.1111/j.1749-6632.2010.05835.x.
- Results publication: PubMed 26321065Reich W, Bilkenroth U, Schubert J, Wickenhauser C, Eckert AW. Surgical treatment of bisphosphonate-associated osteonecrosis: Prognostic score and long-term results. J Craniomaxillofac Surg. 2015 Nov;43(9):1809-22. doi: 10.1016/j.jcms.2015.07.035. Epub 2015 Aug 6.
- Individual participant dataSharing planned: No
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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.
Emeline Noaillon, MD principal investigator
Centre Hospitalier Sud Francilien
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteonecrosis Due to Drugs, Jaw, run by Centre Hospitalier Sud Francilien at 5 sites in France.
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 4 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: stopped early, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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?
The study was stopped early (reason given: rate of inclusions too low). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence of osteonecrosis of the jaw (time frame: within 3 months after surgery). 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 NCT04257721, which also lists 9 linked publications.
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 26 Nov 2024.