UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011670
Receipt number R000013602
Scientific Title Randomized, open label, controlled clinical trial of eldcalcitol for falls prevention in postmenopausal osteoporotic patients with depression.
Date of disclosure of the study information 2013/09/10
Last modified on 2019/12/25 14:17:52

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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 or person

Institute

Tokushima University Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013602


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name