Predictive Score for Maxillary Osteonecrosis After Invasive Oral Surgery (PREV-ONM)

Centre Hospitalier Sud Francilien

Status: Terminated

Conditions: Osteonecrosis Due to Drugs, Jaw

Study type: Observational

Funder types: Other

Identifiers

NCT04257721

2019-A01495-52

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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