Predictive Score for Maxillary Osteonecrosis After Invasive Oral Surgery

NCT ID: NCT04257721

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-10
• Study Completion Date: 2022-04-06

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Sud Francilien

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emeline Noaillon, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Sud Francilien

Locations

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, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 12966493 (View on PubMed)

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. J Oral Maxillofac Surg. 2007 Mar;65(3):369-76. doi: 10.1016/j.joms.2006.11.003. No abstract available.

Reference Type: BACKGROUND

PMID: 17307580 (View on PubMed)

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--2014 update. J Oral Maxillofac Surg. 2014 Oct;72(10):1938-56. doi: 10.1016/j.joms.2014.04.031. Epub 2014 May 5.

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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.

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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 2015 Aug 6.

Reference Type: BACKGROUND

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Other Identifiers

2019-A01495-52

Identifier Type: -

Identifier Source: org_study_id