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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004375
Receipt No. R000005228
Scientific Title Study on preventive effect of risedronate administration on aromatase inhibitor-induced bone mineral loss in the endoclinical therapy for postmenopausal breast cancer patients
Date of disclosure of the study information 2010/11/15
Last modified on 2013/10/12

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Basic information
Public title Study on preventive effect of risedronate administration on aromatase inhibitor-induced bone mineral loss in the endoclinical therapy for postmenopausal breast cancer patients
Acronym Effect of risedronate on aromatase inhibitor-induced bone mineral loss in the postmenopausal breast cancer
Scientific Title Study on preventive effect of risedronate administration on aromatase inhibitor-induced bone mineral loss in the endoclinical therapy for postmenopausal breast cancer patients
Scientific Title:Acronym Effect of risedronate on aromatase inhibitor-induced bone mineral loss in the postmenopausal breast cancer
Region
Japan

Condition
Condition Hormone-receptor positive, postmenopausal primary breast cancer
Classification by specialty
Endocrinology and Metabolism Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Assessing preventive effect of risedronate administration on aromatase inhibitor-induced bone mineral loss in the postmenopausal breast cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes change from baseline on 18 month in bone mineral density
Key secondary outcomes change from baseline on 18 month in bone turnover markers

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 An aromatase inhibitor, such as Anasrozole, Letrozole or Exemestane
Interventions/Control_2 An aromatase inhibitor + Risedronate, 17.5mg, orally, once a week
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)primary breast cancer (T1-2N0M0)
2)Post menopausal
3)ER+ve
4)HER2-ve
5)consitable eligible to aromatase inhibitors, i.e. ANA, LET and EXE
6) WBC>=3500 and <12,000, Hb>=9.0, PLT >=100,000, T-Bil <=2.0, AST, ALT<=100,CCR >=50ml/min, ECG normal
7) PS 0-1
8)Signed written informed consent
Key exclusion criteria 1) Inflamatory breast cancer
2) Hypersensitivity to any reagents used in this trial.
3) Serious complications
4) Excess alcohol consumption
5) Habitual smoker
6) Family history of hip joint fracture
7) Active dental and/ or periodontal disease which requires treatment
8) Withdrawal of informed concent
9) Patients who are judged inappropriate for the clinical trial by doctors
Target sample size 64

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masakazu Toi
Organization Graduate School of Medicine Kyoto University
Division name Breast Surgery
Zip code
Address 54 Shogoin Kawara-cho, Sakyo-ku, Kyoto, Japan
TEL 075-751-3660
Email toi@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoharu Sugie
Organization Graduate School of Medicine Kyoto University
Division name Breast Surgery
Zip code
Address 54 Shogoin Kawara-cho, Sakyo-ku, Kyoto, Japan
TEL 075-751-3660
Homepage URL
Email sugie@kuhp.kyoto-u.ac.jp

Sponsor
Institute Graduate School of Medicine Kyoto University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
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 京都大学病院

Other administrative information
Date of disclosure of the study information
2010 Year 11 Month 15 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
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 Terminated
Date of protocol fixation
2010 Year 09 Month 27 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 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
2010 Year 10 Month 12 Day
Last modified on
2013 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005228

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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