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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005905
Receipt No. 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

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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
Email 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
Email skan@a7.keio.jp

Sponsor
Institute otolaryngology head and Neck Surgery
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006984

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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