UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013863 |
|---|---|
| Receipt number | R000016173 |
| Scientific Title | The efficacy of the use of denosumab in the prevention of aromatase inhibitor-induced bone loss in postmenopausal women with hormone receptor-positive breast cancer who are currently on or will iniate an aromatase inhibitor in the adjuvant setting |
| Date of disclosure of the study information | 2014/05/12 |
| Last modified on | 2018/09/10 14:18:34 |
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Basic information
Public title
The efficacy of the use of denosumab in the prevention of aromatase inhibitor-induced bone loss in postmenopausal women with hormone receptor-positive breast cancer who are currently on or will iniate an aromatase inhibitor in the adjuvant setting
Acronym
The efficacy of the use of denosumab in the prevention of AI-induced bone loss in postmenopausal patients
Scientific Title
The efficacy of the use of denosumab in the prevention of aromatase inhibitor-induced bone loss in postmenopausal women with hormone receptor-positive breast cancer who are currently on or will iniate an aromatase inhibitor in the adjuvant setting
Scientific Title:Acronym
The efficacy of the use of denosumab in the prevention of AI-induced bone loss in postmenopausal patients
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the use of denosumab in the prevention of aromatase inhibitor-induced bone loss in postmenopausal women with stage 1-3a hormone receptor-positive breast cancer who are currently on, or will iniate an aromataze inhibitor in the adujuvant setting
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
the percent change in lumbar spine(L1-L4)BMD from baseline to 12 months
Key secondary outcomes
1) the percent change in lumbar spine(L1-L4)BMD from basebaline to 6 months,two years, three years, four years and five years.
2) the percent change in total hip BMD from basebaline to 6 months, 12 months, two years, three years, four years and five years.
3) To identify changes in serum markers of bone turnover, TRACP-5b and BAP, from basebaline to 6 months, 12 months, two years, three years, four years and five years.
4) Disease-free survival
5) Bone metastasis-free survival
6) Overall survival
7) Distant recurrence-free survival
Base
Study type
Interventional
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
subcutaneous injection of denosumab every 6 months
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Adequately diagnosed and treated invasive breast cancer defined as 1.Clinical stage 1,2 or 3a 2.Patients with breast cancer whose tumor were removed by an appropriate surgical procedure such as mastectomy or breast conserving surgery
2) ER and PgR positive defined with immunohistochemical staining
3) Postmenopausal status defined by one of the following 1.women >54 years with cessation of menses 2.spontaneous cessation of menses within the past 1 years, but amenorrheic in women <55 years, and according to the definition of 'postmenopausal range' for FSH and estradiol level 3.bilateral oophorectomy
4) Lumbar spine, total hip or femoral neck BMD equivalent to a YAM classification of -1.0 to -2.5
5) ECOG Performance status of 0 to 2
6) Patients who have completed chemothrapy >4 weeks prior to study entry
7) Patients who have discontinued the following drugs known as affect to the skeleton more than 4 weeks oral bisphosphonates, estrogen, raloxifene, calcitonin, vitamin K, activated vitamin D, ipriflavone
8) A written informed consent is obtained
Key exclusion criteria
1) Diagnosis of clinical or radiological disant metastasis before inclusion
2) Invasive bilateral breast cancer
3) Received prior treatment with intravenous bisphosphonates within the past 12 months
4) Following diseases which may interfere with DXA scan such as severe scoliosis, vertebral diseases
5) Current active dental problems including infection of the teeth or jawbone. Recent (within 6 weeks) or planned dental or jaw surgery(e.g., extraction, implants)
6) Other conditions judged as inappropriate for the study by the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Taguchi |
Organization
Kyoto Prefectural University of medicine
Division name
Department of Endocrine and Breast Surgery
Zip code
Address
465 kajii-cho Kawaramachi Hirokoji kamigyo-ku Kyoto Japan
TEL
075-251-5534
ttaguchi@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | yoshimi ouchi |
Organization
Kyoto Prefectural University of medicine
Division name
Department of Endocrine and Breast Surgery
Zip code
Address
465 kajii-cho Kawaramachi Hirokoji kamigyo-ku Kyoto Japan
TEL
075-251-5534
Homepage URL
y-ouchi@koto.kpu-m.ac.jp
Sponsor or person
Institute
Department of Endocrine and breast cancer, Kyoto Prefectural University of medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of medicine
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 | 05 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
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
Main results already published
Date of protocol fixation
| 2013 | Year | 06 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 21 | 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 | 05 | Month | 01 | Day |
Last modified on
| 2018 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016173
