Bone and Joint InfectionNCT03808285
Denosumab Related Osteonecrossi of the Jaw : : an Emergent and Potentially Complex Bone and Joint Infection
An observational study of Bone and Joint Infection and Osteomyelitis, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bone and Joint Infection, Osteomyelitis, Adverse Drug Event
- What is being tested?
- mandibular osteomylitis
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2013to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients having a mandibular osteomylelitis due to DENOSUMAB betwwen 01/01/2013 and 31/12/2018 and managed at the Lyon Bone and joint infection refence Center
Who may be able to join
- patients having a mandibular osteomylelitis due to DENOSUMAB
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Bone and Joint Infection, Osteomyelitis, Adverse Drug Event
- Being tested
- mandibular osteomylitis
- Keywords
- bone and joint infection, osteomyelitis, mandibular, denosumab
- Medical subject headings
- Osteomyelitis, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mandibular osteomylitisOther
| Study group | Role | What they receive |
|---|---|---|
| mandibular osteomylitis | description of mandibular osteomylitis due to denosumab Receives: Other: mandibular osteomylitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of mandibular osteomyelitis
description of mandibular osteomyelitis
Measured: 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 outcomes (3)
Duration of antibiotics
Description of the duration and strategies of antibiotic treatments used (double-agent therapy, monotherapy)
Measured: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
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.
Measured: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
management of mandibular osteomyelitis by medical team
description of medical and surgical strategies : data availables in consultation report
Measured: all data are available at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start1 Jan 2013
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone and Joint InfectionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eugénie MABRUT, Hospices Civils de Lyon
- Investigators
- TRISTAN FERRY, MD,PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03808285
- Sponsor's protocol ID
- 18-334
- Status last verified
- Jan 2019
- First submitted
- 4 Jan 2019
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Denosumab Related Osteonecrossi of the Jaw : : an Emergent and Potentially Complex Bone and Joint Infection
- ClinicalTrials.gov ID
- NCT03808285
- Acronym / sponsor ID
- 18-334
- Conditions
- Bone and Joint Infection, Osteomyelitis, Adverse Drug Event
- Keywords
- bone and joint infection, osteomyelitis, mandibular, denosumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 17 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mandibular osteomylitis | – | Other: mandibular osteomylitisdescription of mandibular osteomylitis due to denosumab |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients having a mandibular osteomylelitis due to DENOSUMAB betwwen 01/01/2013 and 31/12/2018 and managed at the Lyon Bone and joint infection refence Center
Key inclusion criteria (1 listed)
- patients having a mandibular osteomylelitis due to DENOSUMAB
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mandibular osteomylitis | Other | mandibular osteomylitis |
Primary outcome
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
3 secondary outcomes
Duration of antibiotics
Time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TRISTAN FERRY, MD,PhD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone and Joint Infection and Osteomyelitis, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2019.