UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031227 |
|---|---|
| Receipt number | R000035661 |
| Scientific Title | Efficacy on zoledronate therapy for diffuse sclerosing osteomyelitis of the mandible. (Transitioned to jRCT) |
| Date of disclosure of the study information | 2018/09/01 |
| Last modified on | 2023/02/18 12:20:03 |
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Basic information
Public title
Efficacy on zoledronate therapy for diffuse sclerosing osteomyelitis of the mandible. (Transitioned to jRCT)
Acronym
Efficacy on zoledronate therapy for DSO.
Scientific Title
Efficacy on zoledronate therapy for diffuse sclerosing osteomyelitis of the mandible. (Transitioned to jRCT)
Scientific Title:Acronym
Efficacy on zoledronate therapy for DSO.
Region
| Japan |
Condition
Condition
Diffuse sclerosing osteomyelitis of the mandible.
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of effects of zoledronate therapy for diffuse sclerosing osteomyelitis of the mandible.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain score(visual analogue scale:VAS) of the mandible after one year from the administration of zoledronate.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Single administration of zoledronate(4mg)
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patient was diagnosed with diffuse sclerosing osteomyelitis of the mandible by imaging examination.
Key exclusion criteria
The high risk case of critical complications induced by intravenous administration of zoledronate.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | Akashi |
Organization
Kobe University Hospital
Division name
Department of Oral and Maxillofacial Surgery
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe-city
TEL
078-382-6213
akashim@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | |
| Last name | Akashi |
Organization
Kobe University Hospital
Division name
Department of Oral and Maxillofacial Surgery
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe-city
TEL
078-382-6213
Homepage URL
akashim@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Hospital
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
Kobe University Clinical Research Ethical Committee
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe-city , Hyog o
Tel
0 7 8 -3 8 2 -6 6 6 9
c e rb @ m e d .ko b e -u.a c .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
| 2018 | Year | 09 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Transitioned to jRCT, jRCTs051180011
Management information
Registered date
| 2018 | Year | 02 | Month | 09 | Day |
Last modified on
| 2023 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035661
