UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033725 |
|---|---|
| Receipt number | R000038457 |
| Scientific Title | Therapeutic effect on disodium pamidronate administration to diffuse sclerosing mandible osteomyelitis |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2022/08/15 12:14:16 |
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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
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
n4160@ompu.ac.jp
Sponsor or person
Institute
Department of Oral and Maxillofacial Surgery, Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038457
