UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040394 |
|---|---|
| Receipt number | R000046040 |
| Scientific Title | Examination of Osteoporosis Treatment for Breast Cancer Treatment-related Bone Loss Evaluation of bone quality by TBS (Trabecular Bone Score) |
| Date of disclosure of the study information | 2020/05/20 |
| Last modified on | 2020/10/30 14:52:40 |
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Basic information
Public title
Examination of Osteoporosis Treatment for Breast Cancer Treatment-related Bone Loss
Evaluation of bone quality by TBS (Trabecular Bone Score)
Acronym
Examination of Osteoporosis Treatment for Breast Cancer Treatment-related Bone Loss
Evaluation of bone quality by TBS (Trabecular Bone Score)
Scientific Title
Examination of Osteoporosis Treatment for Breast Cancer Treatment-related Bone Loss
Evaluation of bone quality by TBS (Trabecular Bone Score)
Scientific Title:Acronym
Examination of Osteoporosis Treatment for Breast Cancer Treatment-related Bone Loss
Evaluation of bone quality by TBS (Trabecular Bone Score)
Region
| Japan |
Condition
Condition
Aromatase Inhibitor-Associated Bone
Loss in Breast Cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of osteoporosis treatment performed in our hospital for bone loss associated with breast cancer treatment from the bone quality.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
TBS(Trabecular Bone Score) and rate of change before, 6 and 12 months after the start of osteoporosis treatment
Key secondary outcomes
Bone density and bone metabolism markers and rate of change before, 6 and 12 months after the start of osteoporosis treatment
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1.Patients who receive breast cancer treatment with aromatase inhibitor at our hospital
2.Treatment of osteoporosis in "Women's HealthCare Outpatient clinic for Breast Cancer Patients"
3.Using Bisphosphonate or denosumab for osteoporosis
4.Osteoporosis treatment has been started and continued with the same drug for more than 1 year
Key exclusion criteria
1.Patients who received continuous administration of osteoporosis before visit "Women's HealthCare Outpatient clinic for Breast Cancer Patients"
2.Has bone metastases
3.changed drug on the way
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Emi |
| Middle name | |
| Last name | Onuma |
Organization
Yokohama City University Medical Center
Division name
Department of Gynecology
Zip code
2320024
Address
4-57,Urafune-cho,Minami-ku,Yokohama,Kanagawa
TEL
0452615656
emionuma@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Emi |
| Middle name | |
| Last name | Onuma |
Organization
Yokohama City University Medical Center
Division name
Department of Gynecology
Zip code
2320024
Address
4-57,Urafune-cho,Minami-ku,Yokohama,Kanagawa
TEL
0452615656
Homepage URL
emionuma@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
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
Yokohama City University Medical Center
Address
4-57,Urafune-cho,Minami-ku,Yokohama,Kanagawa
Tel
0452615656
emionuma@yokohama-cu.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
| 2020 | Year | 05 | Month | 20 | 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
70
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
| 2020 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 24 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 10 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 10 | Month | 30 | Day |
Other
Other related information
a Retrospective observational Study
Management information
Registered date
| 2020 | Year | 05 | Month | 13 | Day |
Last modified on
| 2020 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046040
| 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 |
