Osteonecrosis Due to Drugs, Jaw
Conditions
Keywords
jaw osteonecrosis, biphosphonates, antiangiogenic agents, oral surgery
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.
Interventions
None listed
Sponsors
Centre Hospitalier Sud Francilien
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| occurrence of osteonecrosis of the jaw | within 3 months after surgery | occurrence of osteonecrosis of the jaw |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of post-operative healing (bone and gingival) and comparison to each patient's UCONNS score. | within 3 months after surgery | 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) |
Countries
France
Outcome results
None listed