Denosumab Related Osteonecrossi of the Jaw : : an Emergent and Potentially Complex Bone and Joint Infection

Completed

• Conditions: Adverse Drug Event; Bone and Joint Infection; Osteomyelitis
• Interventions: Other: mandibular osteomylitis

• Registration Number: NCT03808285
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

The aim of this study is to adescription of mandibular osteomylitis in patients having had a treatment by DENOSUMAB. Indeed, one of the adverse effect ot this molecule is to induce mandibular infection.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-01
• Study First Submitted: 2019-01-04
• Study First Submitted QC: 2019-01-15
• Study First Posted: 2019-01-17
• Last Update Submitted: 2019-01-30
• Last Update Posted: 2019-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• patients having a mandibular osteomylelitis due to DENOSUMAB

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Exclusion Criteria

• none

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
mandibular osteomylitis	mandibular osteomylitis	description of mandibular osteomylitis due to denosumab

Primary Outcome Measures

Name	Time	Method
Rate of mandibular osteomyelitis	Entire description can be made at the outcome which is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption	description of mandibular osteomyelitis

Secondary Outcome Measures

Name	Time	Method
Duration of antibiotics	Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption	Description of the duration and strategies of antibiotic treatments used (double-agent therapy, monotherapy)
Rate of Treatment Failure	Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption	Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin. Analyse of risk factor.
management of mandibular osteomyelitis by medical team	all data are available at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption	description of medical and surgical strategies : data availables in consultation report

Trial Locations

Locations (1)

Hospices Civils de Lyon; 🇫🇷 Lyon, France