UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048655 |
|---|---|
| Receipt number | R000055398 |
| Scientific Title | Multicenter observational study on imaging classification of drug-related osteonecrosis of the jaw (MRONJ) |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2024/02/21 12:24:58 |
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Basic information
Public title
Multicenter observational study on imaging classification of drug-related osteonecrosis of the jaw (MRONJ)
Acronym
Multicenter observational study on imaging classification of drug-related osteonecrosis of the jaw (MRONJ)
Scientific Title
Multicenter observational study on imaging classification of drug-related osteonecrosis of the jaw (MRONJ)
Scientific Title:Acronym
Multicenter observational study on imaging classification of drug-related osteonecrosis of the jaw (MRONJ)
Region
| Japan |
Condition
Condition
Medication-related Osteonecrosis of the Jaws
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establishment of diagnosis
Basic objectives2
Others
Basic objectives -Others
Determining MRONJ classification method
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. incidence of MRONJ types
2. prognosis of each type by treatment
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with MRONJ who visited participating institutions between January 1, 2011 and December 31, 2021
Key exclusion criteria
Patients undergoing conebeam CT scan only
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Mitsunobu |
| Middle name | |
| Last name | Otsuru |
Organization
Nagasaki University Hospital
Division name
Department of Oral surgery
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki-shi
TEL
095-819-7698
ootsuru@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Mitsunobu |
| Middle name | |
| Last name | Otsuru |
Organization
Nagasaki University Hospital
Division name
Department of Oral surgery
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki-shi
TEL
095-819-7698
Homepage URL
ootsuru@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki-shi
Tel
095-819-7229
gaibushikin@ml.nagasaki-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.kwcs.jp/jss77/index.html
Publication of results
Unpublished
Result
URL related to results and publications
https://www.kwcs.jp/jss77/index.html
Number of participants that the trial has enrolled
777
Results
Imaging of MRONJ was investigated in a multicenter study. Periosteal reactions were found in 34.1% (265/777). This was considered a possible indicator of treatment. In addition, 3.5% (27/777) of cases were diagnosed as MRONJ even though there was no osteolysis on CT. The appropriate treatment and outcome of each type, as well as imaging modalities other than CT, such as MRI and scintigraphy, will be discussed in the future.
Results date posted
| 2024 | Year | 02 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with MRONJ who visited a participating institution between January 1, 2011 and December 31, 2021 and had a CT scan within one month of their initial visit were included.
Participant flow
If the principal investigator or a research associate at the research institution receives a request from a research subject, etc., to refuse to use the information, the principal investigator or research associate will confirm and record the refusal. The principal investigator who confirms the request for refusal of use will take appropriate measures not to provide the information if it has not been provided. If the information has already been provided, the Principal Investigator will be informed of the withdrawal as soon as possible, together with the identification code. Upon receipt of the report, the principal investigator will remove all information regarding the subject's research from the analysis.
Adverse events
none
Outcome measures
Date of initial visit
Patient background gender, age, primary disease, presence of diabetes, presence of steroids
Bone metabolism modifiers type and duration of administration
Clinical manifestations presence or absence of drainage, presence or absence of guttation, presence or absence of pain, presence or absence of swelling, presence or absence of separation of putrefied bone
Blood tests white blood cell count, lymphocyte count, creatinine, albumin
Treatment presence or absence of treatment, and if yes, method and date of treatment
Outcome MRONJ outcomeon the date of the last visit CT scan
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2022 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Date of first visit, sex, age, primary disease, diabetes, steroid administration, type and duration of antiresorptive agents , clinical symptoms (drainage, guttation, pain, swelling, osteolysis), blood tests (leukocytes, lymphocytes, creatinine, albumin), treatment and treatment date, prognosis, CT findings
Management information
Registered date
| 2022 | Year | 08 | Month | 12 | Day |
Last modified on
| 2024 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055398
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