Predictive Score For Maxillary Osteonecrosis After Invasive Oral Surgery

Osteonecrosis Due to Drugs, Jaw Clinical Trial

— PREV-ONM  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04257721
• Other study ID #: 2019-A01495-52
• Status: Terminated
• Start date: October 10, 2019
• Est. completion date: April 6, 2022

Study information

• Verified date: April 2022
• Source: Centre Hospitalier Sud Francilien
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 metastasis of a solid tumour).

Data are collected during the usual follow-up of patients during the first 3 months following surgery.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: April 6, 2022
• Est. primary completion date: April 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Osteonecrosis
• Osteonecrosis Due to Drugs, Jaw

Locations

Country	Name	City	State
France	Centre Hospitalier Intercommunal Robert Ballanger	Aulnay-sous-Bois
France	Centre Hospitalier Sud Francilien	Corbeil-Essonnes
France	Centre Hospitalier Universitaire Henri Mondor	Créteil
France	Centre Hospitalier Bretagne Atlantique	Vannes
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Sud Francilien

Country where clinical trial is conducted

France, 

References & Publications (9)

Advisory 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. — View Citation

Allen 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. Review. — View Citation

Gaudin 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 — View Citation

Landesberg 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. Review. — View Citation

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. — View Citation

Peddi 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. Review. — View Citation

Qi 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 — View Citation

Reich 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 201 — View Citation

Ruggiero 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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence of osteonecrosis of the jaw	occurrence of osteonecrosis of the jaw	within 3 months after surgery
Secondary	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)	within 3 months after surgery