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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013039
Receipt No. R000015185
Scientific Title A multicenter clinical trial of the effect of raloxifene hydrochloride for the prevention of health care problems caused by bilateral oophorectomy due to endometrial cancer
Date of disclosure of the study information 2014/01/31
Last modified on 2014/01/31

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Basic information
Public title A multicenter clinical trial of the effect of raloxifene hydrochloride for the prevention of health care problems caused by bilateral oophorectomy due to endometrial cancer
Acronym A multicenter clinical trial of the effect of raloxifene hydrochloride after endometrial cancer surgeries.
Scientific Title A multicenter clinical trial of the effect of raloxifene hydrochloride for the prevention of health care problems caused by bilateral oophorectomy due to endometrial cancer
Scientific Title:Acronym A multicenter clinical trial of the effect of raloxifene hydrochloride after endometrial cancer surgeries.
Region
Japan

Condition
Condition endometrial cancer
Osteoporosis
Classification by specialty
Endocrinology and Metabolism Obsterics and gynecology Orthopedics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the impact of bilateral oophorecotmy due to endometrial cancer in patients on bone mineral density or lipid profiles and to elucidate the prevention effect of raloxifene
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The percentage change of bone mineral density of lumber spine and femoral neck
Key secondary outcomes Lipid profiles

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is 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 Group I: alfacalcidol (1microgram/day) and calcium aspartate 1.2g/day
Drug admimistration period is 24 months.
Interventions/Control_2 Group II: alfacalcidol (1microgram/day) and Raloxifene (60mg/day) and calcium aspartate 1.2g/day
Drug admimistration period is 24 months.
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
25 years-old <=
Age-upper limit
75 years-old >=
Gender Female
Key inclusion criteria The patients who were diagnosed with endometrial cancer and underwent a surgery including bilateral oophorectomy at the five institutions participating in this study between 2004 and 2011.
Key exclusion criteria Patients who refuse participation in this study.
Patients who had taken bisphosphonates, estrogen or progestin within the previous 1 year, or vitamin D3, vitamin K2, or ipiriflavone within previous 3 months. Patients who raloxifene, alfacalcidol, or Calcium L-Aspartate Hydrate is contraindicated for.
Patients whose lumber BMD was above +2.5 S.D. at the enrollment.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenjiro Sawada
Organization Osaka University Graduate School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 2-2, Yamadaoka, Suita, Osaka, Japan
TEL 81668793354
Email daasawada@gyne.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Nakamura
Organization Osaka University Graduate School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 2-2, Yamadaoka, Suita, Osaka, Japan
TEL 81668793354
Homepage URL
Email kojinakamura@hotmail.co.jp

Sponsor
Institute Osaka University Graduate School of Medicine, Department of Obstetrics and Gynecology
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
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

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 31 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 Completed
Date of protocol fixation
2007 Year 06 Month 11 Day
Date of IRB
Anticipated trial start date
2007 Year 07 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
2014 Year 01 Month 31 Day
Last modified on
2014 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015185

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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