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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032089
Receipt No. 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

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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
Email 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
Email asakatakuya@den.hokudai.ac.jp

Sponsor
Institute Hokkaido University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036607

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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