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

Adverse Drug Event Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03808285
• Other study ID #: 18-334
• Status: Completed
• Start date: January 1, 2013
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• patients having a mandibular osteomylelitis due to DENOSUMAB

Exclusion Criteria:

Related Conditions & MeSH terms

• Adverse Drug Event
• Arthritis, Infectious
• Bone and Joint Infection
• Communicable Diseases
• Drug-Related Side Effects and Adverse Reactions
• Infection
• Osteomyelitis

Intervention

Other:
• mandibular osteomylitis

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of mandibular osteomyelitis	description 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
Secondary	Duration of antibiotics	Description of the duration and strategies of antibiotic treatments used (double-agent therapy, monotherapy)	Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Secondary	Rate of Treatment Failure	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.	Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Secondary	management of mandibular osteomyelitis by medical team	description of medical and surgical strategies : data availables in consultation report	all data are available at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption