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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023659
Receipt No. 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

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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 Obsterics 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
Email 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
Email teragyne@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027252

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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