UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032089 |
|---|---|
| Receipt number | R000036607 |
| Scientific Title | Evaluation of Usefulness of Bisphosphanate for diffuse sclerosing osteomyelitis of the jaw |
| Date of disclosure of the study information | 2018/04/15 |
| Last modified on | 2018/10/03 17:54:26 |
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Basic information
Public title
Evaluation of Usefulness of Bisphosphanate
for diffuse sclerosing osteomyelitis of the jaw
Acronym
Evaluation of Usefulness of BP for DSO
Scientific Title
Evaluation of Usefulness of Bisphosphanate
for diffuse sclerosing osteomyelitis of the jaw
Scientific Title:Acronym
Evaluation of Usefulness of BP for DSO
Region
| Japan |
Condition
Condition
Diffuse Sclerosing Osteomyelitis of the jaw
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The usefulness of bisphosphonate for Diffuse Sclerosing Osteomyelitis of the jaw
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of Visual Analogue Scale (VAS) of pain after administaration of bisphosphonate
Key secondary outcomes
Safety: general morbidities,side effects
SUVmax of the FDF-PET
correlation between Bone scintigraphy and pain area
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
Pamidronate disodium
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)over 15 years old
2)written informed consent
3)Performance Status 0 or 1
Key exclusion criteria
1)Patients diagnosed Anti-resorptive agents-related ONJ
2)Patients who received other bisphosphonate.3)Children of 15 years or under.
4)pregnancy, nursing woman or possibly pregnant woman.5)Patients with severe renal disorders(BUN:=<1.5 upper limit of normal,Cr:=<1.5 upper limit of normal)
6)patients who are contraindications for Voltaren
Target sample size
13
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshimasa Kiyagawa |
Organization
Graduate School of Dental Medicine, Hokkaido University
Division name
Oral Diagnosis and Medicine
Zip code
Address
Nishi 7, Kita 13, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-4280
ykitagawa@den.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuya Asaka |
Organization
Graduate School of Dental Medicine, Hokkaido University
Division name
Oral Diagnosis and Medicine
Zip code
Address
Nishi 7, Kita 13, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-4280
Homepage URL
asakatakuya@den.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Dental Medicine, Hokkaido University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 04 | Month | 15 | 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
| 2018 | Year | 03 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 03 | Day |
Last modified on
| 2018 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036607
