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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005568
Receipt No. R000006147
Scientific Title A randomized phase II study of efficacy of risendronate for the prevention of letrozole-induced bone mineral loss in post-menopausal breast cancer patients
Date of disclosure of the study information 2011/05/07
Last modified on 2020/03/13

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Basic information
Public title A randomized phase II study of efficacy of risendronate for the prevention of letrozole-induced bone mineral loss in post-menopausal breast cancer patients
Acronym Hiroshima FEmare with Actonel Trial(H-FEAT)
Scientific Title A randomized phase II study of efficacy of risendronate for the prevention of letrozole-induced bone mineral loss in post-menopausal breast cancer patients
Scientific Title:Acronym Hiroshima FEmare with Actonel Trial(H-FEAT)
Region
Japan

Condition
Condition breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of risendronate for the prevention of letrozole-induced bone mineral loss in post-menopausal breast cancer patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes rate of change from baseline to 12 months in lumbar spine (L1-L4) bone mineral density
Key secondary outcomes rate of change from baseline to 6 months in lumbar spine (L1-L4) bone mineral density
rate of change from baseline to 12 months in total hip bone mineral density
rate of change from baseline to 12 months in bone turnover markers

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 period: 12months
risedronate: 17.5mg/week
letrozole: 2.5mg/day
Interventions/Control_2 period: 12months
letrozole: 2.5mg/day
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 Postmenopausal women with hormonereceptor-positive early invasive breast cancer
Patient who completed surgery, chemotherapy and radiotherapy as primary therapy within recent 12 weeks
Eligible for letrozole as adjuvant therapy
T-score is greater than -2.5 in lumbar spine (L1-L4)
Patient who have no fracture in lumber spine and hip
Patient who is not administered any medication that alter bone mineral density
Proved to be eligible for administration of risedronate after consultation of dentistry
Adequate general condition
ECOG PS 0-2
Provided written Informed consent
Key exclusion criteria Metastatic breast cancer
Patient who have lumber spine or hip fracture
Previous history of endocrine therapy for breast cancer within recent 12 months
Patient who is not suitable condition for measurement of bone mineral density
Patient who is planned to undergo dentistry surgery within 6 weeks
Contraindication of study drugs
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Morihito
Middle name
Last name Okada
Organization Hiroshima University Hospital
Division name Respiratory Surgery
Zip code 734-8551
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
TEL 082-257-5869
Email morihito@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name Shinsuke
Middle name
Last name Sasada
Organization Hiroshima University Hospital
Division name Breast Surgery
Zip code 734-8551
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
TEL 082-257-5869
Homepage URL http://home.hiroshima-u.ac.jp/genge/
Email shsasada@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University
Institute
Department

Funding Source
Organization Hiroshima University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Center for Integrated Medical Research, Hiroshima University
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
Tel 082-257-1752
Email protocol@cimr.hiroshima-u.ac.jp

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 広島大学病院(広島県)、県立広島病院(広島県)、広島総合病院(広島県)

Other administrative information
Date of disclosure of the study information
2011 Year 05 Month 07 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 Completed
Date of protocol fixation
2011 Year 05 Month 06 Day
Date of IRB
2011 Year 05 Month 06 Day
Anticipated trial start date
2011 Year 05 Month 01 Day
Last follow-up date
2015 Year 03 Month 01 Day
Date of closure to data entry
2015 Year 06 Month 01 Day
Date trial data considered complete
2015 Year 09 Month 01 Day
Date analysis concluded
2015 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 05 Month 07 Day
Last modified on
2020 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006147

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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