UMIN-CTR Clinical Trial

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
Email	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
Email	mumeda@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046102