UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Cohort study evaluating the efficacy of denosumab to protect against aromatase inhibitor-induced bone loss in Japanese breast cancer patients.
Title of the study (Brief title)	Cohort study evaluating the efficacy of denosumab to protect against aromatase inhibitor-induced bone loss in Japanese breast cancer patients. (CYBORG003)
Region	Japan

Condition
Condition	Breast Cancer Osteoporosis
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the efficacy and safety of denosumab to protect against aromatase inhibitor-induced bone loss in Japanese breast cancer patients who are undergoing adjuvant aromatase inhibitor therapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Bone mineral density changes
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. Non-metastatic breast cancer patients within 6 months after commencing postoperative aromatase inhibitor treatment. 2. Bone mineral densities have been measured within 1 month before/after commencing aromatase inhibitor treatment. 3. Subject is willing and able to provide signed consent.
Key exclusion criteria	1. Subject with prior allergy history to therapeutic agents used in this study 2. Evidence of with hypocalcemia 3. Known renal deficiency 4. Any organic or psychiatric disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results.
Target sample size	500

Research contact person
Name of lead principal investigator	TAKAFUMI SANGAI
Organization	Chiba University Graduate School of Medicine
Division name	Department of General Surgery
Address	1-8-1 Inohana Chuo-ku Chiba, Japan 260-8670
TEL	043-226-2269
Email	sangai-jpn@umin.net

Public contact
Name of contact person	TAKAFUMI SANGAI
Organization	Chiba University Graduate School of Medicin
Division name	Department of General Surgery
Address	1-8-1 Inohana Chuo-ku Chiba, Japan 260-8670
TEL	043-226-2269
Homepage URL
Email	sangai-jpn@umin.net

Sponsor
Institute	CYBORG (Chiba Youth Breast Oncology Research Group)
Institute
Department

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)

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	亀田総合病院（千葉県） 千葉県がんセンター（千葉県） 千葉大学医学部附属病院（千葉県） 東京歯科大学市川総合病院（千葉県） 船橋市立医療センター（千葉県）

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 26 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 05 Month 20 Day
Anticipated trial start date	2014 Year 09 Month 01 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	Unpublished
URL releasing results
Results	The number of registered patient is too small than expected, so we are unable to make a planned analysis.
Other related information	1. At the patient registration * Age, height, weight, PS * Past history, history of present illness, family history * Pathological findings of primary tumor (TNM classification, grading, Ki-67 expression status, number of lymph node metastasis, hormone receptor expression status, HER2 receptor expression status) * Treatment content (history of surgery, date of surgery, history of chemotherapy, history of irradiation treatment, start date and type of aromatase inhibitor, denosumab administration start date, the presence or absence of treatment for bone mineral loss, the contents of treatment for bone mineral loss except denosumab) * Bone mineral density (measurement date, BMD, YAM, T-score) 2. During the treatment, and at the end of the treatment * Treatment content * Bone mineral density * The presence or absence of fracture * Adverse events and laboratory values of grade 3 or higher * Dose reduction, discontinuation, or change of drug * Metastasis and recurrence * Clinical outcome (the last follow up date, date of death, cause of death,) 3. Observation and survey schedule At aromatase inhibitor start date, 6 months after, 12 months after, and then every year. Observation and survey are allowed to perform within one month before or after the specified date.

Management information
Registered date	2014 Year 08 Month 26 Day
Last modified on	2016 Year 11 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017264