UMIN-CTR Clinical Trial

Public title

Multicenter prospective study on oral management for preventing medication-related osteonecrosis of the jaw in patients receiving high-dose antiresorptive agent

Acronym

Prevention of medication-related osteonecrosis of the jaw in patients receiving high-dose antiresorptive agent

Scientific Title

Multicenter prospective study on oral management for preventing medication-related osteonecrosis of the jaw in patients receiving high-dose antiresorptive agent

Scientific Title:Acronym

Prevention of medication-related osteonecrosis of the jaw in patients receiving high-dose antiresorptive agent

Region

Japan

Condition

Patients with cancer receiving high-dose antiresorptive agent

Classification by specialty

Oral surgery	Dental medicine	Adult

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Prevention of medication-relative osteonecrosis of the jaw caused by high-dose antiresorptive agent

Basic objectives2

Others

Basic objectives -Others

Research for risk factors and prevention of medication-relative osteonecrosis of the jaw by high-dose antiresorptive agent

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

onset of Medication-related osteonecrosis of the jaw (MRONJ)

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with cancer receiving high-dose antiresorptive agent

Key exclusion criteria

edentrous patient

Target sample size

300

Name of lead principal investigator

1st name	Masahiro
Middle name
Last name	Umeda

Organization

Nagasaki University Graduate School of Biomedical Sciences

Division name

Department of Clinical Oral Oncology

Zip code

8528588

Address

1-7-1, Sakamoto, Nagasaki-Shi

TEL

81-095-819-7698

Email

mumeda@nagasaki-u.ac.jp

Name of contact person

1st name	Masahiro
Middle name
Last name	Umeda

Organization

Nagasaki University Graduate School of Biomedical Sciences

Division name

Department of Clinical Oral Oncology

Zip code

8528588

Address

1-7-1, Sakamoto, Nagasaki-Shi

TEL

81-095-819-7698

Homepage URL

Email

mumeda@nagasaki-u.ac.jp

Institute

Nagasaki University Graduate School of Biomedical Sciences

Institute

Department

Personal name

Organization

Nagasaki University Graduate School of Biomedical Sciences

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Nagasaki University Graduate School of Biomedical Sciences

Address

1-7-1, Sakamoto, Nagasaki-Shi

Tel

81-095-819-7698

Email

mumeda@nagasaki-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

02

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2019

Year

07

Month

23

Day

Date of IRB

2019

Year

08

Month

20

Day

Anticipated trial start date

2019

Year

08

Month

20

Day

Last follow-up date

2023

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Selection criteria
1. Cancer patients receiving a high-dose bone resorption inhibitor(ZOMETA or RANMARK SUBCUTANEOUS INJECTION) among the patients who first visited a dentist (dental/oral surgery) at each participating facility. Include patients who have received bone resorption inhibitors but are currently on suspension or discontinuation
2. Age 20 years or older, regardless of gender.
3. Patients who have been given sufficient explanations to participate in this study, and with sufficient understanding and who have given their informed consent in writing(or their sponsor).

Exclusion criteria
1. edentulous jaw
2. In addition, patients who are judged by the researchers, etc. to be inappropriate as study subjects.

Data Collection
1. Patient background: gender, Age, P.S., Disease name, Type of BMA, Duration of BMA administration, co-morbidity, Smoking history, Drunk history, concomitant medication
2. Blood tests: hemoglobin, white blood cell count, albumin, creatinine
3. Panoramic X-ray examination: Apical lesion more than 3mm, alveolar bone resorption more than 1/2, root fracture
4. Oral hygiene: OHI-S
5. Periodontal examination: pocket depth, bleeding on probing, mobility
6. Oral examination: Redness, swelling, abscess, pus discharge
7. Extraction procedures: gingival incision, bone reduction, crown / root amputation, , the state of the wound (open vs. closed)
8. Presence and duration of withdrawal of bone resorption inhibitor, type and administration period of antibiotics before and after tooth extraction
MRONJ onset: onset, site, stage

Registered date

2020

Year

02

Month

10

Day

Last modified on

2023

Year

05

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044339