UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033743 |
|---|---|
| Receipt number | 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 | 2024/02/21 08:48:08 |
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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
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
hasetaku@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
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
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
30
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
| 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
Trial is finished
Management information
Registered date
| 2018 | Year | 08 | Month | 14 | Day |
Last modified on
| 2024 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038486
