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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039449
Receipt No. R000044339
Scientific Title Multicenter prospective study on oral management for preventing medication-related osteonecrosis of the jaw in patients receiving high-dose antiresorptive agent
Date of disclosure of the study information 2020/02/10
Last modified on 2020/02/10

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Basic information
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
Condition Patients with cancer receiving high-dose antiresorptive agent
Classification by specialty
Oral surgery Dental medicine Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
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

Assessment
Primary outcomes onset of Medication-related osteonecrosis of the jaw (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 Patients with cancer receiving high-dose antiresorptive agent
Key exclusion criteria edentrous patient
Target sample size 300

Research contact person
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

Public contact
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

Sponsor
Institute Nagasaki University Graduate School of Biomedical Sciences
Institute
Department

Funding Source
Organization Nagasaki University Graduate School of Biomedical Sciences
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 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
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 02 Month 10 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 Open public 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
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

Management information
Registered date
2020 Year 02 Month 10 Day
Last modified on
2020 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044339

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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