UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021760 |
|---|---|
| Receipt number | R000025093 |
| Scientific Title | Multicenter retrospective observational study on the treatment of Medication-Related Osteonecrosis of the Jaw(MRONJ) |
| Date of disclosure of the study information | 2016/04/05 |
| Last modified on | 2016/04/03 17:30:33 |
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Basic information
Public title
Multicenter retrospective observational study on the treatment of Medication-Related Osteonecrosis of the Jaw(MRONJ)
Acronym
Multicenter retrospective observational study on the treatment of MRONJ
Scientific Title
Multicenter retrospective observational study on the treatment of Medication-Related Osteonecrosis of the Jaw(MRONJ)
Scientific Title:Acronym
Multicenter retrospective observational study on the treatment of MRONJ
Region
| Japan |
Condition
Condition
Medication-Related Osteonecrosis pf the Jaw(MRONJ)
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elucidation of Prognostic facors in the treatment and course of MRONJ
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prognosis after medical treatment MRONJ
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient from January 1, 2009 until December 31, 2015 and medical treatment the MRONJ in participating centers, and there is a medical record for the survey items
Key exclusion criteria
Below, it shall be applicable even one excluded.
1. Patient record was insufficient on the survey items.
2. Patinets who had the intention of nonparticipation.
3. patients principal investigator has determined to be inappropriate as a subject.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Saki Hayashida |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Clinical Oral Oncology
Zip code
Address
1-7-1, Sakamoto, Nagasaki 852-8588, Japan
TEL
095-819-7698
sakihaya@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Saki Hayashida |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Clinical Oral Oncology
Zip code
Address
1-7-1, Sakamoto, Nagasaki 852-8588, Japan
TEL
095-819-7698
Homepage URL
sakihaya@nagasaki-u.ac.jp
Sponsor or person
Institute
Department of Clinical Oral Oncology, Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 04 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 02 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Methods
Survey item:age, sex, underlying disease,medical history, type and duration of BMA use, risk factors, BMA of preoperative washout, preoperative blood test data(WBC, BUN, Cr, AST, ALT, TP, Alb,ect.), operative procedure, course, X-ray and CT photos of before and after surgery
2. Statistical analysis
Perform a single logistic regression analysis for each factor. To calculate the odds ratios and 95% confidence interval and P value.
The factors that influence the development of events from P <0.05, and past research as explanatory variables, perform a multivariate logistic regression analysis.
Management information
Registered date
| 2016 | Year | 04 | Month | 03 | Day |
Last modified on
| 2016 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025093
