UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009378 |
|---|---|
| Receipt number | 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 18:00:29 |
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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
| Obstetrics 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
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
yhirai-ind@umin.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011024
