UMIN-CTR Clinical Trial

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

Postmenopausal osteoporosis

Classification by specialty

Medicine in general	Endocrinology and Metabolism	Geriatrics

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kyushu-University Hospital

Institute

Department

Personal name

Organization

Kyushu-University Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

11

Month

12

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2013

Year

11

Month

12

Day

Last modified on

2013

Year

11

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010303