UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058876 |
|---|---|
| Receipt number | R000067336 |
| Scientific Title | Assessment of the factor of sepulcher bone separation in medication-related osteonecrosis of jaw |
| Date of disclosure of the study information | 2025/08/24 |
| Last modified on | 2025/08/24 10:52:44 |
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Basic information
Public title
Assessment of the factor of sepulcher bone separation in medication-related osteonecrosis of jaw
Acronym
Assessment of the factor of sepulcher bone separation in medication-related osteonecrosis of jaw
Scientific Title
Assessment of the factor of sepulcher bone separation in medication-related osteonecrosis of jaw
Scientific Title:Acronym
Assessment of the factor of sepulcher bone separation in MRONJ
Region
| Japan |
Condition
Condition
medication-related osteonecrosis of jaw
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Identification of factors causing sepulchral bone separation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification of factors causing sepulchral bone separation.
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 who have been or are currently receiving oral or injectable bisphosphonates, anti-RANKL antibodies, anti-sclerostin antibodies, or parathyroid hormones for the treatment of osteoporosis or bone metastasis of cancer, and who will undergo sequestrectomy with a diagnosis of MRONJ.
Key exclusion criteria
If the patient (or legal representative) does not consent to the purpose of this study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Ohba |
| Middle name | |
| Last name | Seigo |
Organization
Showa Medical University
Division name
Department of Oral and Maxillofacial Surgery
Zip code
145-8515
Address
2-1-1 Kitasenzoku, Ota-ku, Tokyo
TEL
03-3787-1151
sohba@dent.showa-i.ac.jp
Public contact
Name of contact person
| 1st name | Ohba |
| Middle name | |
| Last name | Seigo |
Organization
Showa Medical University
Division name
Department of Oral and Maxillofacial Surgery
Zip code
145-8515
Address
2-1-1 Kitasenzoku, Ota-ku, Tokyo
TEL
03-3787-1151
Homepage URL
sohba@dent.showa-i.ac.jp
Sponsor or person
Institute
Showa Medical University
Institute
Department
Personal name
Funding Source
Organization
Showa Medical 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
Showa Medical University
Address
2-1-1 Kitasenzoku, Ota-ku, Tokyo
Tel
03-3787-1151
sohba@dent.showa-i.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
| 2025 | Year | 08 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2025 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Omics analysis, histological analysis, and molecular biological analysis will be performed using collected specimens to identify the cell groups and functional molecules that contribute to sequestration. This will allow us to identify the spatial location of cells and proteins and analyze their functions. Patient information will be used as supplementary information during this process.
Management information
Registered date
| 2025 | Year | 08 | Month | 24 | Day |
Last modified on
| 2025 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067336
