UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046818 |
|---|---|
| Receipt number | R000053422 |
| Scientific Title | Effects of Adjuvant Endocrine Therapy on Bone Mineral Density and Microstructure in Women with Breast Cancer: Analysis Using Second-Generation High-Resolution Peripheral Quantitative Computed Tomography |
| Date of disclosure of the study information | 2022/02/03 |
| Last modified on | 2024/02/04 10:18:06 |
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Basic information
Public title
Effects of Adjuvant Endocrine Therapy on Bone Mineral Density and Microstructure in Women with Breast Cancer: Analysis Using Second-Generation High-Resolution Peripheral Quantitative Computed Tomography
Acronym
Effects of Adjuvant Endocrine Therapy on Bone Mineral Density and Microstructure in Women with Breast Cancer: Analysis Using Second-Generation High-Resolution Peripheral Quantitative Computed Tomography
Scientific Title
Effects of Adjuvant Endocrine Therapy on Bone Mineral Density and Microstructure in Women with Breast Cancer: Analysis Using Second-Generation High-Resolution Peripheral Quantitative Computed Tomography
Scientific Title:Acronym
Effects of Adjuvant Endocrine Therapy on Bone Mineral Density and Microstructure in Women with Breast Cancer: Analysis Using Second-Generation High-Resolution Peripheral Quantitative Computed Tomography
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery | Orthopedics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We evaluated changes in bone mineral density (BMD) and bone microstructure associated with aromatase inhibitor (AI) treatment
Basic objectives2
Others
Basic objectives -Others
changes in BMD using DXA at the lumbar spine, total hip, femoral neck, and bone turnover marker levels.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
change in the total volumetric BMD (Tt.vBMD), trabecular vBMD (Tb.vBMD), and cortical vBMD (Ct.vBMD) at the distal radius and tibia
Key secondary outcomes
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
1 breast cancer
2 woman who will start aromatase inhitor
Key exclusion criteria
Osteoporosis
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | susumu |
| Middle name | |
| Last name | eguchi |
Organization
Nagasaki university hospital
Division name
Surgery
Zip code
852-8501
Address
1-7-1 Sakamoto
TEL
0958197316
skuba@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Sayaka |
| Middle name | |
| Last name | Kuba |
Organization
Nagasaki university hospital
Division name
Surgery
Zip code
8528501
Address
1-7-1 Sakamoto
TEL
0958197316
Homepage URL
skuba@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University Hospital
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
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto
Tel
0958197198
gaibushikin@ml.nagasaki-u.ac.jp
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
| 2022 | Year | 02 | Month | 03 | 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
| 2021 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 02 | Month | 03 | Day |
Last modified on
| 2024 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053422
