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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017571
Receipt No. R000020360
Scientific Title The effect of anastrozole 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 2015/05/14
Last modified on 2015/05/14

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Basic information
Public title The effect of anastrozole on bone mineral density during the first 5 years of adjuvant treatment in postmenopausal women with early breast cancer
Acronym The effect of anastrozole on bone mineral density during the first 5 years of adjuvant treatment in postmenopausal women with early breast cancer
Scientific Title The effect of anastrozole 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 anastrozole 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 anastrozole 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 Confirmatory
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 50 months at the lumbar spine and femoral neck
Bone fracture rate during 5 years

Base
Study type

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Initiaion of bisphosphonate (risedronate or alendronate) when patients were diagnosed with osteoporosis having a T-score of -2.5 or lower.
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

Not applicable
Gender Female
Key inclusion criteria Primary breast cancer in stage 0 to IIIC
Treatment with anastrozole
Postmenopausal E2 <30pg/ml
Written informed concent
Key exclusion criteria Patients already treated as osteoporosis
Target sample size 55

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadao Shimizu
Organization Tokyo Women's Medical University Medical Center East
Division name Department of Breast Surgery
Zip code
Address 2-1-10 Nishiogu, Arakawa-ku, Tokyo 116-8567, Japan
TEL 03-3810-1111
Email shimitsu@dnh.twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Hirano
Organization Tokyo Women's Medical University Medical Center East
Division name Department of Breast Surgery
Zip code
Address 2-1-10 Nishiogu, Arakawa-ku, Tokyo 116-8567, Japan
TEL 03-3810-1111
Homepage URL
Email ahirasu@dnh.twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University
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
2015 Year 05 Month 14 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2004 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2004 Year 07 Month 26 Day
Last follow-up date
2015 Year 04 Month 01 Day
Date of closure to data entry
2015 Year 04 Month 01 Day
Date trial data considered complete
2015 Year 05 Month 14 Day
Date analysis concluded
2015 Year 05 Month 14 Day

Other
Other related information

Management information
Registered date
2015 Year 05 Month 14 Day
Last modified on
2015 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020360

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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