Unique ID issued by UMIN | UMIN000004375 |
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Receipt number | 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 09:06:02 |
Study on preventive effect of risedronate administration on aromatase inhibitor-induced bone mineral loss in the endoclinical therapy for postmenopausal breast cancer patients
Effect of risedronate on aromatase inhibitor-induced bone mineral loss in the postmenopausal breast cancer
Study on preventive effect of risedronate administration on aromatase inhibitor-induced bone mineral loss in the endoclinical therapy for postmenopausal breast cancer patients
Effect of risedronate on aromatase inhibitor-induced bone mineral loss in the postmenopausal breast cancer
Japan |
Hormone-receptor positive, postmenopausal primary breast cancer
Endocrinology and Metabolism | Breast surgery |
Malignancy
NO
Assessing preventive effect of risedronate administration on aromatase inhibitor-induced bone mineral loss in the postmenopausal breast cancer
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
change from baseline on 18 month in bone mineral density
change from baseline on 18 month in bone turnover markers
Interventional
Parallel
Randomized
Open -no one is blinded
No treatment
2
Treatment
Medicine |
An aromatase inhibitor, such as Anasrozole, Letrozole or Exemestane
An aromatase inhibitor + Risedronate, 17.5mg, orally, once a week
20 | years-old | <= |
Not applicable |
Female
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
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
64
1st name | |
Middle name | |
Last name | Masakazu Toi |
Graduate School of Medicine Kyoto University
Breast Surgery
54 Shogoin Kawara-cho, Sakyo-ku, Kyoto, Japan
075-751-3660
toi@kuhp.kyoto-u.ac.jp
1st name | |
Middle name | |
Last name | Tomoharu Sugie |
Graduate School of Medicine Kyoto University
Breast Surgery
54 Shogoin Kawara-cho, Sakyo-ku, Kyoto, Japan
075-751-3660
sugie@kuhp.kyoto-u.ac.jp
Graduate School of Medicine Kyoto University
Ministry of Education, Culture, Sports, Science and Technology
NO
京都大学病院
2010 | Year | 11 | Month | 15 | Day |
Unpublished
Terminated
2010 | Year | 09 | Month | 27 | Day |
2011 | Year | 04 | Month | 01 | Day |
2010 | Year | 10 | Month | 12 | Day |
2013 | Year | 10 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005228
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