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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000012269
Receipt No. R000010303
Scientific Title Effects of Eldecalcitol and/or Raloxifene on insulin sensitivity and carotid intima-media thickness in postmenopausal woman.
Date of disclosure of the study information 2013/11/12
Last modified on 2013/11/12

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Basic information
Public title Effects of Eldecalcitol and/or Raloxifene on insulin sensitivity and carotid intima-media thickness in postmenopausal woman.
Acronym Effects of Eldecalcitol and/or Raloxifene on insulin sensitivity and carotid intima-media thickness in postmenopausal woman.
Scientific Title Effects of Eldecalcitol and/or Raloxifene on insulin sensitivity and carotid intima-media thickness in postmenopausal woman.
Scientific Title:Acronym Effects of Eldecalcitol and/or Raloxifene on insulin sensitivity and carotid intima-media thickness in postmenopausal woman.
Region
Japan

Condition
Condition Postmenopausal osteoporosis
Classification by specialty
Medicine in general Endocrinology and Metabolism Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effects of Eldecalcitol and/or Raloxifene on insulin sensitivity and carotid intima-media thickness in postmenopausal woman.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Effect on improving insulin resistance: changes of HOMA-IR at 12 months

Effect on improving arteriosclerosis: changes of BMD at 12 month
Key secondary outcomes

Base
Study type

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

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Raloxifene (60mg/day)
Interventions/Control_2 Eldecalcidol (0.75micro;g/day)
Interventions/Control_3 Raloxifene (60mg/day) +eldecalcidol (0.75micro;g/day)
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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1. Postmenopausal state more than 5 years

2. Criteria of osteoporosis (The guide of lifestyle-related diseases fracture risk

Have any existing insufficiency fracture
(over 50 years old)

Have no any existing insufficiency fractur
(%YAM<70)

Postmenopausal women who have no existing insufficiency (70<%YAM<80) and satisfying at least one of the following requirements

(1) Family history of bone fracture of proximal part of femur

(2) Primary osteoporotic fracture, 10-year fracture risk assessment more than 15% and less than 75 years old using FRAX

(3) Fracture risk assessment of lifestyle related disease (type 2 diabetes mellitus, CKD stage 3 or more advanced)
Key exclusion criteria The following subjects will be excluded from the study:

1.Pregnants women, women suspected of being pregnant, or lactating women

2.Patients who have been diagnosed or history of thromboembolism (including deep vein thrombosis, pulmonary embolism, retinal vein occlusion)

3.Patients who is a long term and immovable

4.Patients who is an antiphospholipid syndrome

5.Patients who have a hypersensitivity to Raloxifene or Eldecalcidol

6.Patients who are treated with bisphosphonates, or within 3 month after the suspension of administration

7.Patients whom the principle investigators or other investigators consider unsuitable
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun Hayashi
Organization Kyushu-University Hospital
Division name Department of General internal medicine
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan
TEL 092-642-5909
Email hayashij@gim.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kyouko Okada
Organization Kyushu-University Hospital
Division name Department of General internal medicine
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan
TEL 092-642-5909
Homepage URL
Email okyouko@gim.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu-University Hospital
Institute
Department

Funding Source
Organization Kyushu-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
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

Other administrative information
Date of disclosure of the study information
2013 Year 11 Month 12 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 Enrolling by invitation
Date of protocol fixation
2012 Year 01 Month 24 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 24 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
2013 Year 11 Month 12 Day
Last modified on
2013 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010303

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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