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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009378
Receipt No. R000011024
Scientific Title Effects of Eldecalcitol and Raloxifene on the suppression of new vertebral fracture with osteoporosis in perimenopausal women or ovariectomy patients: Randomized controlled trial
Date of disclosure of the study information 2012/11/21
Last modified on 2012/11/21

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Basic information
Public title Effects of Eldecalcitol and Raloxifene on the suppression of new vertebral fracture with osteoporosis in perimenopausal women or ovariectomy patients: Randomized controlled trial
Acronym Effects of Eldecalcitol and Raloxifene on the suppression of new vertebral fracture with osteoporosis in perimenopausal women or ovariectomy patients
Scientific Title Effects of Eldecalcitol and Raloxifene on the suppression of new vertebral fracture with osteoporosis in perimenopausal women or ovariectomy patients: Randomized controlled trial
Scientific Title:Acronym Effects of Eldecalcitol and Raloxifene on the suppression of new vertebral fracture with osteoporosis in perimenopausal women or ovariectomy patients
Region
Japan

Condition
Condition osteoporosis in perimenopausal women or ovariectomy patients
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of Eldecalcitol on the suppression of new vertebral fracture with osteoporosis in perimenopausal women or ovariectomy patients, compared with the raloxifene.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary end point is incident of new vertebral fractures.
Key secondary outcomes The secondary end points included the changes in bone mineral density of lumbar spine (L2-L4 BMD) and changes in bone turnover markers (tartrate resistant acid phosphatase-5b (TRACP5b), bone-alkaline phosphatase (BAP)).

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Eldecalcitol (0.75µg/cap.): once a day for 36months
Interventions/Control_2 Raloxifene (60mg/Tab.): once a day for 36months
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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Women selected according to the diagnostic criteria for osteoporosis based on Japanese Guideline for the prevention and treatment of Osteoporosis -up dated 2011-
Key exclusion criteria 1,If the disease has progressed apparently.
2,If the patient is no longer any reason to visit.
3,Others,
If the patient wishes to have the discontinuation of treatment with this protocol. or
If the doctor determines that difficult to continue treatment with this protocol.
Target sample size 360

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideo Matsui
Organization Tokyo Women's Medical University Hospital
Division name Department of Obstetrics and Gynecology
Zip code
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yasuo Hirai
Organization Tokyo Women's Medical University Hospital
Division name Department of Obstetrics and Gynecology
Zip code
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, JAPAN
TEL
Homepage URL
Email yhirai-ind@umin.ac.jp

Sponsor
Institute Tokyo Women's Medical University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization None

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
2012 Year 11 Month 21 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 Open public recruiting
Date of protocol fixation
2012 Year 10 Month 02 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 02 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
2012 Year 11 Month 21 Day
Last modified on
2012 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011024

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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