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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031227
Receipt No. R000035661
Scientific Title Efficacy on zoledronate therapy for diffuse sclerosing osteomyelitis of the mandible.
Date of disclosure of the study information 2018/09/01
Last modified on 2019/02/12

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Basic information
Public title Efficacy on zoledronate therapy for diffuse sclerosing osteomyelitis of the mandible.
Acronym Efficacy on zoledronate therapy for DSO.
Scientific Title Efficacy on zoledronate therapy for diffuse sclerosing osteomyelitis of the mandible.
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
Middle name
Last name Shungo Furudoi
Organization Kobe University Hospital
Division name Department of Oral and Maxillofacial Surgery
Zip code
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe-city
TEL 078-382-6213
Email furudoi@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shungo Furudoi
Organization Kobe University Hospital
Division name Department of Oral and Maxillofacial Surgery
Zip code
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe-city
TEL 078-382-6213
Homepage URL
Email furudoi@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Hospital
Institute
Department

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
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 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 Open public recruiting
Date of protocol fixation
2018 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 01 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 02 Month 09 Day
Last modified on
2019 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035661

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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