Predictive Score for Maxillary Osteonecrosis After Invasive Oral Surgery

NCT04257721 | Terminated

• 1 other identifier: 2019-A01495-52
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 5

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.

Conditions

Osteonecrosis Due to Drugs, Jaw

Keywords

jaw osteonecrosis; biphosphonates; antiangiogenic agents; oral surgery

Outcome Measures

Primary Outcomes (1)

• occurrence of osteonecrosis of the jaw

  occurrence of osteonecrosis of the jaw

  within 3 months after surgery

Secondary Outcomes (1)

• Frequency of post-operative healing (bone and gingival) and comparison to each patient's UCONNS score.

  within 3 months after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Sud Francilien: lead

Study Sites (5)

Centre Hospitalier Intercommunal Robert Ballanger

Aulnay-sous-Bois, 93600, France

Location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91106, France

Location

Centre Hospitalier Universitaire Henri Mondor

Créteil, 94010, France

Location

Centre Hospitalier Bretagne Atlantique

Vannes, 56017, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Related Publications (9)

• 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.

  PMID: 12966493 BACKGROUND

• 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.

  PMID: 17307580 BACKGROUND

• 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.

  PMID: 25234529 BACKGROUND

• 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.

  PMID: 23605142 BACKGROUND

• 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.

  PMID: 19371816 BACKGROUND

• 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.12455. Epub 2015 Nov 3.

  PMID: 26362756 BACKGROUND

• 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.

  PMID: 22898302 BACKGROUND

• 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.

  PMID: 21291478 BACKGROUND

• 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.

  PMID: 26321065 BACKGROUND

Study Officials

• Emeline Noaillon, MD

  Centre Hospitalier Sud Francilien

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 6, 2020
• Study Start: October 10, 2019
• Primary Completion: April 6, 2022
• Study Completion: April 6, 2022
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)