UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024896 |
|---|---|
| Receipt number | R000028649 |
| Scientific Title | Effect of parathyroid hormone therapy for mediation related osteonecrosis of the jaw. |
| Date of disclosure of the study information | 2016/11/18 |
| Last modified on | 2021/09/15 18:08:06 |
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Basic information
Public title
Effect of parathyroid hormone therapy for mediation related osteonecrosis of the jaw.
Acronym
Drug therapy for MRONJ
Scientific Title
Effect of parathyroid hormone therapy for mediation related osteonecrosis of the jaw.
Scientific Title:Acronym
Drug therapy for MRONJ
Region
| Japan |
Condition
Condition
Medication related osteonecrosis of the jaw
Classification by specialty
| Oral surgery | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To preserve jaw bone for the patients with MRONJ by using parathyroid hormone therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Spontaneous sequestration separation 6 months after starting drug therapy.
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Parathyroid hormone
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
Osteonecrosis of the jaw by using osteoporosis drug
Key exclusion criteria
Patients with malignant cancer in the bone
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Hirota |
Organization
Yokohama CIty University
Division name
Oral and Maxillofacial Surgery
Zip code
Address
3-9 Fukuura, Kanazawaku, Yokohama City
TEL
045-787-2800
mhirota@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Hirota |
Organization
Yokohama City University
Division name
Oral and Maxillofacial Surgery
Zip code
Address
3-9 Fukuura, Kanazawaku, Yokohama City
TEL
045-787-2800
Homepage URL
mhirota@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Yokohama City 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
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
B160204009
Org. issuing International ID_1
Yokohama CIty University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 18 | 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
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 18 | Day |
Last modified on
| 2021 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028649
