UMIN-CTR Clinical Trial

Basic information
Public title	Randomized, open label, controlled clinical trial of eldcalcitol for falls prevention in postmenopausal osteoporotic patients with depression.
Acronym	Efficacy of eldcalcitol for falls prevention in postmenopausal osteoporotic patients with depression.
Scientific Title	Randomized, open label, controlled clinical trial of eldcalcitol for falls prevention in postmenopausal osteoporotic patients with depression.
Scientific Title:Acronym	Efficacy of eldcalcitol for falls prevention in postmenopausal osteoporotic patients with depression.
Region	Japan

Condition
Condition	Falls
Classification by specialty	Geriatrics Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effecacy of eldecalcitol for falls prevention
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Falls rate
Key secondary outcomes	falls related injury Hamilton raing scale for depression physical function bone mineral density mauscle volume markers of bone metabolism falls efficacy scale

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration
Blocking	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	eldecalcitol, 0.75µg/day raloxifene, 60mg/day
Interventions/Control_2	raloxifene, 60mg/day
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	50 years-old <=
Age-upper limit	95 years-old >
Gender	Female
Key inclusion criteria	Postmenopausal osteoporotic patients with depression Aged 50 and over
Key exclusion criteria	Patients who are diagnosed as contraindication of raloxifene treatments Patients who are diagnosed as contraindication of eldecalcitol treatments Patient who have a past history of treatment with vitamin D within 6 months Patient who have a past history of treatment for osteoporosis besides vitamin D in the past 12-months Unsuitable for trial as evaluated by the physician-in-charge Subject who refuse to participate in this study
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Tetsuya Middle name Last name Enishi
Organization	Tokushima University Hospital
Division name	Division of Rehabilitation, Tokushima University Hospital
Zip code	7708503
Address	7708503, Japan
TEL	088-633-9313
Email	enishi.tetsuya@tokushima-u.ac.jp

Public contact
Name of contact person	1st name Tetsuya Middle name Last name Enishi
Organization	Tokushima University Hospital
Division name	Division of Rehabilitation, Tokushima University Hospital
Zip code	7708503
Address	Kuramoto, Tokushima 7708503, Japan
TEL	088-633-9313
Homepage URL
Email	enishi.tetsuya@tokushima-u.ac.jp

Sponsor
Institute	Tokushima University Hospital
Institute
Department

Funding Source
Organization	Tokushima University Hospital
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	IRB for Tokushima universuty hospital
Address	2-50-1, kuramoto, Tokushima
Tel	088-633-9294
Email	awachiken@tokushima-u.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

Other administrative information
Date of disclosure of the study information	2013 Year 09 Month 10 Day

Related information
URL releasing protocol	None
Publication of results	Unpublished

Result
URL related to results and publications	none
Number of participants that the trial has enrolled	0
Results	none
Results date posted	2019 Year 12 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	none
Participant flow	none
Adverse events	none
Outcome measures	none
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 07 Day
Date of IRB	2013 Year 09 Month 07 Day
Anticipated trial start date	2013 Year 09 Month 10 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete	2016 Year 04 Month 30 Day
Date analysis concluded	2016 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date	2013 Year 09 Month 06 Day
Last modified on	2019 Year 12 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013602