UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of the effects of bazedoxifene and eldecalcitol on the health screening results of postmenopausal women
Title of the study (Brief title)	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	Masakazu Terauchi
Organization	Tokyo Medical and Dental University
Division name	Department of Women's Health
Address	Yushima 1-5-45, Bunkyo, Tokyo
TEL	03-5803-4605
Email	teragyne@tmd.ac.jp

Public contact
Name of contact person	Masakazu Terauchi
Organization	Tokyo Medical and Dental University
Division name	Department of Women's Health
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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