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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000013863
Receipt No. 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

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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
Email 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
Email y-ouchi@koto.kpu-m.ac.jp

Sponsor
Institute Department of Endocrine and breast cancer, Kyoto Prefectural University of medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016173

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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