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Recruitment status Terminated
Unique ID issued by UMIN UMIN000011670
Receipt No. R000013602
Official scientific title of the study 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 2014/07/07

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Basic information
Official scientific title of the study Randomized, open label, controlled clinical trial of eldcalcitol for falls prevention in postmenopausal osteoporotic patients with depression.
Title of the study (Brief title) 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 Tetsuya Enishi
Organization Tokushima University Hospital
Division name Division of Rehabilitation, Tokushima University Hospital
Address Kuramoto, Tokushima 7708503, Japan
TEL 088-633-9313
Email enishi.tetsuya@tokushima-u.ac.jp

Public contact
Name of contact person Tetsuya Enishi
Organization Tokushima University Hospital
Division name Division of Rehabilitation, Tokushima University Hospital
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

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status Terminated
Date of protocol fixation
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

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Publication of results Unpublished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

Management information
Registered date
2013 Year 09 Month 06 Day
Last modified on
2014 Year 07 Month 07 Day


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


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