UMIN-CTR Clinical Trial

Basic information
Public title	Therapeutic effect on disodium pamidronate administration to diffuse sclerosing mandible osteomyelitis
Acronym	On the effect of disodium pamidronate on diffuse curable mandibular osteomyelitis
Scientific Title	Therapeutic effect on disodium pamidronate administration to diffuse sclerosing mandible osteomyelitis
Scientific Title:Acronym	On the effect of disodium pamidronate on diffuse curable mandibular osteomyelitis
Region	Japan

Condition
Condition	diffuse sclerosing osteomyelitis
Classification by specialty	Oral surgery Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Diffuse sclerosing osteomyelitis (DSO) is recognized as refractory osteomyelitis. In recent years, it has been reported that disodium pamidronate, a bisphosphonate preparation, has been effective, and also in our department, administration of disodium pamidronate to patients who have long-term illness period in DSO consider.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Dissolve pamidronate disodium in 500ml of raw diet for patients with diffuse osteomyelitis and take IV infusion over 4 hours. The number of doses is only once, but when symptoms such as pain are observed, re-administration is performed at intervals of 3 to 6 months.Comparison of changes in jaw bone due to clinical symptoms and image findings before and after administration of disodium pamidronate, and evaluate the improvement effect of diamid pamidronate on DSO
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who underwent dental oral surgery at Osaka Medical University Hospital and underwent treatment with diamantane pamidronate for DSO
Key exclusion criteria	Patients who did not obtain consent to this study
Target sample size	5

Research contact person
Name of lead principal investigator	1st name Ueno Middle name Last name Takaaki
Organization	Osaka Medical and Pharmaceutical University
Division name	Department of Oral and Maxillofacial Surgery
Zip code	5698686
Address	2-7 Daigakumachi Takatsukishi, Osaka, Japan
TEL	0726831221
Email	n4160@osaka-med.ac.jp

Public contact
Name of contact person	1st name Nakajima Middle name Last name Yoichiro
Organization	Osaka Medical and Pharmaceutical University
Division name	Department of Oral and Maxillofacial Surgery
Zip code	5698686
Address	2-7 Daigakumachi Takatsukishi, Osaka, Japan
TEL	0726831221
Homepage URL
Email	n4160@ompu.ac.jp

Sponsor
Institute	Department of Oral and Maxillofacial Surgery, Osaka Medical and Pharmaceutical University
Institute
Department

Funding Source
Organization	Osaka Medical and Pharmaceutical University
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	Osaka Medical and Pharmaceutical University
Address	2-7 Daigakumachi Takatsukishi, Osaka, Japan
Tel	0726831221
Email	n4160@ompu.ac.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	大阪医科薬科大学病院

Other administrative information
Date of disclosure of the study information	2020 Year 10 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	5
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	Completed
Date of protocol fixation	2019 Year 10 Month 01 Day
Date of IRB	2018 Year 09 Month 10 Day
Anticipated trial start date	2020 Year 10 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Effective judgment based on image findings, clinical findings, blood tests from the time of pamidronate administration completion.

Management information
Registered date	2018 Year 08 Month 12 Day
Last modified on	2022 Year 08 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038457