UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Tetsuya Taguchi
Organization	Kyoto Prefectural University of medicine
Division name	Department of Endocrine and Breast Surgery
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	yoshimi ouchi
Organization	Kyoto Prefectural University of medicine
Division name	Department of Endocrine and Breast Surgery
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 06 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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