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

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 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


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

Value
https://center6.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