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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048004


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name