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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033743
Receipt No. R000038486
Scientific Title A multicenter prospective study of risk factors associated with medication-related osteonecrosis of the jaw after tooth extraction in cancer patients receiving intravenous bisphosphonate or denosumab therapy
Date of disclosure of the study information 2020/04/01
Last modified on 2020/08/15

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Basic information
Public title A multicenter prospective study of risk factors associated with medication-related osteonecrosis of the jaw after tooth extraction in cancer patients receiving intravenous bisphosphonate or denosumab therapy
Acronym A prospective study of MRONJ after tooth extraction in cancer patients
Scientific Title A multicenter prospective study of risk factors associated with medication-related osteonecrosis of the jaw after tooth extraction in cancer patients receiving intravenous bisphosphonate or denosumab therapy
Scientific Title:Acronym A prospective study of MRONJ after tooth extraction in cancer patients
Region
Japan

Condition
Condition Cancer patients receiving high-dose bone-modifying agents who tooth extraction were performed
Classification by specialty
Oral surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to investigate the development of MRONJ after tooth extraction in cancer patients receiving high-dose bone-modifying agents
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incident rate of MRONJ at 2 months after tooth extraction
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 who could be investigated treatment method and prognosis
Cancer patients receiving high-dose bone-modifying agents who tooth extraction were performed
Patients who are over 20 years of age
Key exclusion criteria Patients who reject to participate this study
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Takumi
Middle name
Last name Hasegawa
Organization Kobe University Graduate School of Medicine
Division name Department of Oral and Maxillofacial Surgery
Zip code 6500017
Address 7-5-1, Kusunoki-cho, Chuo-ku, Kobe 650-0017
TEL 078-382-6213
Email hasetaku@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name Takumi
Middle name
Last name Hasegawa
Organization Kobe University Graduate School of Medicine
Division name Department of Oral and Maxillofacial Surgery
Zip code 650-0017
Address 7-5-1, Kusunoki-cho, Chuo-ku, Kobe 650-0017
TEL 078-382-6213
Homepage URL
Email hasetaku@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization Kobe University Graduate School of Medicine
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 the institutional review board of the Kobe University Graduate School of Medicine
Address 7-5-1, Kusunoki-cho, Chuo-ku, Kobe
Tel 078-382-6669
Email kansatsu@med.kobe-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 04 Month 01 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 Enrolling by invitation
Date of protocol fixation
2018 Year 12 Month 01 Day
Date of IRB
2019 Year 03 Month 25 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Enrolling by invitation

Management information
Registered date
2018 Year 08 Month 14 Day
Last modified on
2020 Year 08 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038486

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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