UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter retrospective observational study on the treatment of Medication-Related Osteonecrosis of the Jaw(MRONJ)
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Saki Hayashida
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Clinical Oral Oncology
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	Saki Hayashida
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Clinical Oral Oncology
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 02 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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-bin/ctr_e/ctr_view.cgi?recptno=R000025093