UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021543
Receipt number R000024841
Scientific Title The retrospective study of risk factors of Medication related osteonecrosis of the jaw (MRONJ) after oral surgery
Date of disclosure of the study information 2016/04/01
Last modified on 2018/08/14 00:39:37

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Basic information

Public title

The retrospective study of risk factors of Medication related osteonecrosis of the jaw (MRONJ) after oral surgery

Acronym

The study of risk factors of MRONJ after oral surgery

Scientific Title

The retrospective study of risk factors of Medication related osteonecrosis of the jaw (MRONJ) after oral surgery

Scientific Title:Acronym

The study of risk factors of MRONJ after oral surgery

Region

Japan


Condition

Condition

Medication related osteonecrosis of the jaw

Classification by specialty

Oral surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this retrospective study is to investigate the multivariate relationships among various risk factors including drug holiday and the content of treatment for MRONJ patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The presence or absence of 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

The subjects is the patients with bisphosphonate drug or anti-RANKL monoclonal antibody drug receiving oral surgery at the Department of Oral and Maxillofacial Surgery, Kobe University Graduate School of Medicine and the institutions of research collaboration.

Key exclusion criteria

Patients who principal investigator has determined to be inappropriate as a subject.

Target sample size

600


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takumi Hasegawa

Organization

Kobe University Graduate School of Medicine

Division name

Department of Oral and Maxillofacial Surgery

Zip code


Address

7-5-1, Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan

TEL

078-382-6213

Email

hasetaku@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takumi Hasegawa

Organization

Kobe University Graduate School of Medicine

Division name

Department of Oral and Maxillofacial Surgery

Zip code


Address

7-5-1, Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan

TEL

078-382-6213

Homepage URL


Email

hasetaku@med.kobe-u.ac.jp


Sponsor or person

Institute

Kobe University Graduate School of Medicine

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


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 01 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

2016 Year 03 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 04 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Subjects
Between January 2008 and December 2015, the subjects is the patients with bisphosphonate drug or anti-RANKL monoclonal antibody drug receiving oral surgery at the Department of Oral and Maxillofacial Surgery, Kobe University Graduate School of Medicine and the institutions of research collaboration.
Methods
All of the patients were investigated with regard to demographics, medical background, type and duration of BP use, whether or not they underwent a discontinuation of BP before tooth extraction, the duration of such discontinuation, additional surgical procedures such as incision, bone removal, root amputation and suturing, whether antibiotics were administered before extraction, the condition of the bone around the root of the tooth, the duration of follow-up, primary wound healing with no evident sign of infection, presence or absence of MRONJ, and stage of MRONJ.
Statistical analysis
All of the variables associated with MRONJ were introduced into a multiple logistic regression model. Forward selection methods were used, with the rejection of those variables that did not fit the model significantly. Multivariate odds ratios (ORs) and 95% confidence intervals (CIs) were also calculated for the significant signs. Avalue of p < 0.05was considered statistically significant.


Management information

Registered date

2016 Year 03 Month 18 Day

Last modified on

2018 Year 08 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024841


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name