UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042068 |
|---|---|
| Receipt number | R000048004 |
| Scientific Title | The effects of bazedoxifene and estradiol on the bone mineral density and bone turnover markers in postmenopausal women |
| Date of disclosure of the study information | 2021/06/14 |
| Last modified on | 2020/10/09 16:17:16 |
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Basic information
Public title
The effects of bazedoxifene and estradiol on the bone mineral density and bone turnover markers in postmenopausal women
Acronym
The effects of bazedoxifene and estradiol on the bone mineral density and bone turnover markers in postmenopausal women
Scientific Title
The effects of bazedoxifene and estradiol on the bone mineral density and bone turnover markers in postmenopausal women
Scientific Title:Acronym
The effects of bazedoxifene and estradiol on the bone mineral density and bone turnover markers in postmenopausal women
Region
| Japan |
Condition
Condition
Osteopenia in postmenopausal woman
Classification by specialty
| Obstetrics and Gynecology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of SERM and estradiol on lumbar spine BMD and bone turnover markers in postmenopausal women with osteopenia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in bone turnover markers after 3 months of treatment and lumbar spine BMD after 12 months of treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
12 months treatment with 20mg of bazedoxifene and 1mg of estradiol. Bone turnover markers after 3 months and bone mineral density after 12 months were each mesured.
Interventions/Control_2
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
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
women within 3 years of onset of menopause whose TRACP-5b values were 420 mU/dL or higher
Key exclusion criteria
1) past history of arterial/venous thromboembolism
2) past history of breast cancer
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Ikuko |
| Middle name | |
| Last name | Ota |
Organization
Kurashiki-Heisei Hospital
Division name
Department of Gynecology
Zip code
710-0826
Address
4-3-38 Oimatsucho, Kurashiki-city, Okayama Japan
TEL
086-427-1111
ikucom0195@gmail.com
Public contact
Name of contact person
| 1st name | Ikuko Ota |
| Middle name | |
| Last name | Ikuko Ota |
Organization
Kurashiki-Heisei Hospital
Division name
Department of Gynecology
Zip code
710-0826
Address
4-3-38 Oimatsucho, Kurashiki-city, Okayama Japan
TEL
086-427-1111
Homepage URL
ikucom0195@gmail.com
Sponsor or person
Institute
Kurashiki-Heisei Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Kurashiki Heisei Hospital
Address
4-3-38 Oimatsucho, Kurashiki-city, Okayama Japan
Tel
086-427-1111
ikucom0195@gmail.com
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
| 2021 | Year | 06 | Month | 14 | 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
1500
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
Completed
Date of protocol fixation
| 2006 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2006 | Year | 06 | Month | 14 | Day |
Anticipated trial start date
| 2006 | Year | 04 | Month | 14 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 09 | Day |
Last modified on
| 2020 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048004
