UMIN-CTR Clinical Trial

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	Obsterics 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
Email	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
Email	ikucom0195@gmail.com

Sponsor
Institute	Kurashiki-Heisei Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048004