UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023659 |
|---|---|
| Receipt number | R000027252 |
| Scientific Title | Comparison of the effects of bazedoxifene and eldecalcitol on the health screening results of postmenopausal women |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2017/03/30 16:07:25 |
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Basic information
Public title
Comparison of the effects of bazedoxifene and eldecalcitol on the health screening results of postmenopausal women
Acronym
Comparison of the effects of bazedoxifene and eldecalcitol on the health screening results of postmenopausal women
Scientific Title
Comparison of the effects of bazedoxifene and eldecalcitol on the health screening results of postmenopausal women
Scientific Title:Acronym
Comparison of the effects of bazedoxifene and eldecalcitol on the health screening results of postmenopausal women
Region
| Japan |
Condition
Condition
postmenopausal osteoporosis
Classification by specialty
| Endocrinology and Metabolism | Obstetrics and Gynecology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of a SERM and an activated vitamin D on lumbar spine/hip BMD, bone metabolism markers, health-related QOL, and the results of a health screening program in women diagnosed with postmenopausal osteoporosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
changes in lumbar spine/hip BMD after 12 months of treatment
Key secondary outcomes
changes in bone metabolism markers, health-related QOL, and the results of a health screening program after 12 months of treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are 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
12-month treatment with 20 mg of bazedoxifene
Interventions/Control_2
12-month treatment with 0.75mcg of eldecalcitol
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
| 50 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Female
Key inclusion criteria
patients who need medical treatment of osteoporosis, with one or less spinal fractures
Key exclusion criteria
(1) past history of arterial/venous thromboembolism
(2) past history of urollithiasis
(3) use of aromatase inhibitors for the adjuvant treatment of breast cancer
(4) renal dysfunction with eGFR less than 50 ml/min
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masakazu Terauchi |
Organization
Tokyo Medical and Dental University
Division name
Department of Women's Health
Zip code
Address
Yushima 1-5-45, Bunkyo, Tokyo
TEL
03-5803-4605
teragyne@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masakazu Terauchi |
Organization
Tokyo Medical and Dental University
Division name
Department of Women's Health
Zip code
Address
Yushima 1-5-45, Bunkyo, Tokyo
TEL
03-5803-4605
Homepage URL
teragyne@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hitachinaka General Hospital
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
ひたちなか総合病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 01 | 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
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | 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
| 2016 | Year | 08 | Month | 17 | Day |
Last modified on
| 2017 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027252
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| Registered date | File name |
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| Registered date | File name |
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