UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005568 |
|---|---|
| Receipt number | 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 00:06:40 |
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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
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/
shsasada@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006147
