UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020499 |
|---|---|
| Receipt number | R000023669 |
| Scientific Title | The effect of exemestane on bone mineral density during the first 5 years of adjuvant treatment in postmenopausal women with early breast cancer |
| Date of disclosure of the study information | 2016/01/08 |
| Last modified on | 2016/01/15 13:49:32 |
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Basic information
Public title
The effect of exemestane on bone mineral density during the first 5 years of adjuvant treatment in postmenopausal women with early breast cancer
Acronym
The effect of exemestane on bone mineral density during the first 5 years of adjuvant treatment in postmenopausal women with early breast cancer
Scientific Title
The effect of exemestane on bone mineral density during the first 5 years of adjuvant treatment in postmenopausal women with early breast cancer
Scientific Title:Acronym
The effect of exemestane on bone mineral density during the first 5 years of adjuvant treatment in postmenopausal women with early breast cancer
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of exemestane on bone mineral density during the first 5 years of adjuvant treatment in postmenopausal women with early breast cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
BMD change from baseline to 5 years at the lumbar spine and femoral neck
Key secondary outcomes
BMD change from baseline to 6, 12, 24, 36, 48, and 72 months at the lumbar spine and femoral neck
Bone fracture rate during 5 years
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Primary breast cancer in stage 0 to IIIC
Treatment with exemestane
Postmenopausal E2 <30pg/ml
Written informed consent is obtained
Key exclusion criteria
Patients already treated as osteoporosis
Target sample size
81
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadao Shimizu |
Organization
Medical Center East, Tokyo Women's Medical University
Division name
Department of Breast Surgery
Zip code
Address
2-1-10, Nishiogu, Arakawa-ku, Tokyo, Japan
TEL
03-3810-1111
shimitsu@dnh.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Hirano |
Organization
Medical Center East, Tokyo Women's Medical University
Division name
Department of Breast Surgery
Zip code
Address
2-1-10, Nishiogu, Arakawa-ku, Tokyo, Japan
TEL
03-3810-1111
Homepage URL
ahirasu@dnh.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
東京女子医科大学東医療センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 08 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 11 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: observational study
Patients: postmenopausal breast cancer started with exemestane from 2005 through 2010.
Endpoints:
1. Age
2. Sex
3. starting date and duration of EXE
4. BMD change from baseline to 6, 12, 24, 36, 48, 60, and 72 months at the lumbar spine and femoral neck with DEXA.
5. Bone fracture rate during 5 years
6. Reason of interruption
7. recurrence
8. administration of bisphosphonates
9. observation time
Management information
Registered date
| 2016 | Year | 01 | Month | 08 | Day |
Last modified on
| 2016 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023669
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
