UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis on bone mineral density and prevention of progressive hearing loss in patients with otosclerosis
Title of the study (Brief title)	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	Sho Kanzaki
Organization	Keio University Medical School
Division name	Otolaryngology
Address	35 Shinanomachi Shinjuku
TEL	0333531211
Email	skan@a7.keio.jp

Public contact
Name of contact person	Sho Kanzaki
Organization	Keio university School of medicine
Division name	otolarygology
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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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