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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000021760
Receipt No. 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

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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
Email 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
Email sakihaya@nagasaki-u.ac.jp

Sponsor
Institute Department of Clinical Oral Oncology, Nagasaki University Graduate School of Biomedical Sciences
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025093

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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