UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040560 |
|---|---|
| Receipt number | R000046102 |
| Scientific Title | Multicenter retrospective observational study on treatment and prognosis of Medication-related Osteonecrosis of the Jaw |
| Date of disclosure of the study information | 2020/05/28 |
| Last modified on | 2021/12/07 09:56:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Multicenter retrospective observational study on treatment and prognosis of Medication-related Osteonecrosis of the Jaw
Acronym
Multicenter retrospective observational study on treatment and prognosis of Medication-related Osteonecrosis of the Jaw
Scientific Title
Multicenter retrospective observational study on treatment and prognosis of Medication-related Osteonecrosis of the Jaw
Scientific Title:Acronym
Multicenter retrospective observational study on treatment and prognosis of Medication-related Osteonecrosis of the Jaw
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 treatment
Basic objectives2
Others
Basic objectives -Others
1. Determining the criteria for selecting an appropriate bone resection method for surgical treatment
2. Identification of risk factors associated with poor progress in cases of conservative therapy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Examination of the relationship between treatment results (curing) of MRONJ and each collected item in surgical treatment cases
2. Study on the relationship between MRONJ treatment results (deterioration) and each collection item in conservative therapy cases
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
MRONJ patients who visited each participating facility from April 2008 to May 2020
Key exclusion criteria
Patients who were not treated
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Umeda |
| Middle name | |
| Last name | Masahiro |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Oral and Maxillofacial Surgery, Medical and Dental Sciences, Graduate School of Biomed
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki-shi
TEL
095-819-7698
mumeda@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Umeda |
| Middle name | |
| Last name | Masahiro |
Organization
Nagasaki University
Division name
Department of Oral and Maxillofacial Surgery, Medical and Dental Sciences, Graduate School of Biomed
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki-shi
TEL
095-819-7698
Homepage URL
mumeda@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
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
Department of dentistry and oral surgery, Kansai Medical University Hospital
Department of dentistry and oral surgery, Juko Memorial Nagasaki Hospital
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
| 2020 | Year | 05 | Month | 28 | 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
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
age, sex, primary disease, diabetes, steroid, leukocytes, albumin, creatinine, anti-resorptive agent, duration of administration, site, stage, trigger, CT findings, treatment, extent of bone resection, outcome
Management information
Registered date
| 2020 | Year | 05 | Month | 28 | Day |
Last modified on
| 2021 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046102
