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OpenTrials
Completed

NCT Number: NCT03808285

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

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.

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Key information

Conditions

Bone and Joint Infection Adverse Drug Event Bone Diseases Bone Diseases, Infectious Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Infections Musculoskeletal Diseases Osteomyelitis

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospices Civils de Lyon

Lyon, 69004, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients having a mandibular osteomylelitis due to DENOSUMAB

Exclusion criteria

  • none

Treatment and study plan

mandibular osteomylitis

Other

Primary outcomes

  1. Rate of mandibular osteomyelitis

    Time frame: 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 outcomes

  1. Duration of antibiotics

    Time frame: 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)

  2. Rate of Treatment Failure

    Time frame: 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.

  3. management of mandibular osteomyelitis by medical team

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jan 17, 2019
Registry last updated
Feb 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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