UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013039 |
|---|---|
| Receipt number | 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 22:00:06 |
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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 | Obstetrics 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
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
kojinakamura@hotmail.co.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine, Department of Obstetrics and Gynecology
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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015185
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
