Unique ID issued by UMIN | UMIN000009183 |
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Receipt number | R000010782 |
Scientific Title | The comparison of Eldecalcitol and Alfacalcidol on early osteoporosis caused by Anastrozole / Letrozole for post-operative breast cancer. |
Date of disclosure of the study information | 2012/10/26 |
Last modified on | 2012/10/24 20:07:58 |
The comparison of Eldecalcitol and Alfacalcidol on early osteoporosis caused by Anastrozole / Letrozole for post-operative breast cancer.
The comparison of Eldecalcitol and Alfacalcidol on early osteoporosis caused by Anastrozole / Letrozole for post-operative breast cancer.
The comparison of Eldecalcitol and Alfacalcidol on early osteoporosis caused by Anastrozole / Letrozole for post-operative breast cancer.
The comparison of Eldecalcitol and Alfacalcidol on early osteoporosis caused by Anastrozole / Letrozole for post-operative breast cancer.
Japan |
Secondary osteoporosis
Breast surgery |
Malignancy
NO
To compare the efficacy and safety of Eldecalcitol and Alfacalcidol for bone loss caused by Anastrozole and Letrozole.
Efficacy
Change from baseline to 12 months in lumbar spine BMD
bone turnover marker(TRACP-5b),
QOL(QOL-ACD,QOL-ACD-B)
incidence of fracture (vertebral fractures, non- vertebral fractures),
blood calcium
urinary calcium
creatinine
rate of breast cancer recurrence
Interventional
Parallel
Randomized
Open -no one is blinded
Active
2
Treatment
Medicine |
Eldecalcitol (0.75µg/day)
Alfacalcidol(1.0µg/day)
20 | years-old | <= |
Not applicable |
Female
1. Post-operative mammary carcinoma patients whose TNM stage from 0 to IIIA and under receiving anastrozole.
2. Patients with more than 3 years after menopause.
3. Patients with less than -1.0 T score of lumber or total femoral BMD, or with fragile vertebral fractures.
4. Outpatients
5. Patients acquired informed consent about this study.
1. Using other osteoporosis drugs within 6 months
2. Patients suffered from malignancies except mammary carcinoma.
3. Patients with contraindication for eldecalcitol treatments
4. Patients who have serum calcium levels of above 10.4mg/dL.
5. Patients judged inappropriate by attending physicians.
120
1st name | |
Middle name | |
Last name | Yu Tsubota |
Kansai Medical University
Surgery
2-3-1 sinmachi Hirakata city Osaka
1st name | |
Middle name | |
Last name |
Kansai Medical University
Surgery
2-3-1 sinmachi Hirakata city Osaka
Kansai Medical University
None
Self funding
NO
2012 | Year | 10 | Month | 26 | Day |
Unpublished
Preinitiation
2012 | Year | 09 | Month | 30 | Day |
2012 | Year | 11 | Month | 01 | Day |
2012 | Year | 10 | Month | 24 | Day |
2012 | Year | 10 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010782
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