UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005905 |
|---|---|
| Receipt number | R000006984 |
| Scientific Title | Analysis on bone mineral density and prevention of progressive hearing loss in patients with otosclerosis |
| Date of disclosure of the study information | 2011/07/01 |
| Last modified on | 2018/12/17 16:57:38 |
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Basic information
Public title
Analysis on bone mineral density and prevention of progressive hearing loss in patients with otosclerosis
Acronym
prevention of progressive hearing loss in patients with otosclerosis
Scientific Title
Analysis on bone mineral density and prevention of progressive hearing loss in patients with otosclerosis
Scientific Title:Acronym
prevention of progressive hearing loss in patients with otosclerosis
Region
| Japan |
Condition
Condition
otosclerosis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate whether antibone resorptive drug can prevent hearing loss in patients with otosclerosis
Basic objectives2
Others
Basic objectives -Others
bone density
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
hearing
Key secondary outcomes
bone mineral density
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
anti bone resporptive agent
Interventions/Control_2
SERM
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
female osteoporosis
Key exclusion criteria
less than 20 years old
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sho Kanzaki |
Organization
Keio University Medical School
Division name
Otolaryngology
Zip code
Address
35 Shinanomachi Shinjuku
TEL
0333531211
skan@a7.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sho Kanzaki |
Organization
Keio university School of medicine
Division name
otolarygology
Zip code
Address
35 Shinanomachi Shinjuku Tokyo
TEL
03-3353-1211
Homepage URL
skan@a7.keio.jp
Sponsor or person
Institute
otolaryngology head and Neck Surgery
Institute
Department
Personal name
Funding Source
Organization
grant
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Address
Tel
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
慶應義塾大学病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | 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
Completed
Date of protocol fixation
| 2009 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | 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
| 2011 | Year | 07 | Month | 01 | Day |
Last modified on
| 2018 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006984
