Unique ID issued by UMIN | UMIN000012489 |
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Receipt number | R000014621 |
Scientific Title | Efficacy of anti-RANKL human antibody (Denosumab) on prevention of osteoporosis with primary biliary cirrhosis |
Date of disclosure of the study information | 2013/12/04 |
Last modified on | 2016/01/04 15:50:18 |
Efficacy of anti-RANKL human antibody (Denosumab) on prevention of osteoporosis with primary biliary cirrhosis
Efficacy of Denosumab for osteoporosis patients with PBC
Efficacy of anti-RANKL human antibody (Denosumab) on prevention of osteoporosis with primary biliary cirrhosis
Efficacy of Denosumab for osteoporosis patients with PBC
Japan |
Osteoporosis in biopsy-proven PBC who was not pretreated with denosumab and/or bisphosphonate in recent 6 months
Hepato-biliary-pancreatic medicine |
Others
NO
To investigate the effect of denosumab on prevention of osteoporosis with PBC
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
Percent change of bone mineral density (BMD) in 6 months and 12 months
1)Percent change of bone metabolism markers in 6 months and 12 months
2)Correlation between serum activated vitamin D levels and BMD in 6 months and 12 months
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
For osteoporosis patients who need treatment based on PBC treatment guideline, 60mg of denosumab will be subcutaneously injected every 6 months for 12 months. All patients will take activated vitamin D. In the case of hypocalcemia, calcium will be administrated appropriately. PBC patients who do not meet osteoporosis treatment criteria will be followed.
20 | years-old | <= |
Not applicable |
Male and Female
1)Osteoporosis in biopsy-proven PBC who was not pretreated with denosumab and/or bisphosphonate in recent 6 months
2)Patients given written consent after being provided with sufficient explanation about participation in this clinical trial
1)Cancer patients with bone metastasis or expected bone metastasis
2) Hypocalcemia
3) Women who wish to be pregnant or are pregnant, or in lactation
4)Hypersensitivity to the denosumab
5)Cancer patients on cancer treatment or anti-hormonal therapy
6)Dental therapy during this trial
7)Long term use of bisphosphonate and have the possibility of atypical fracture
8)severe skin infection
20
1st name | |
Middle name | |
Last name | Kenichi Ikejima |
Juntendo University School of Medicine
Department of Gastroenterology
2-1-1, Hongo, Bunkyo-ku,Tokyo
03-3813-3111
ikejima@juntendo.ac.jp
1st name | |
Middle name | |
Last name | Reiko Yaginuma |
Juntendo University School of Medicine
Department of Gastroenterology
2-1-1, Hongo, Bunkyo-ku, Tokyo
03-3813-3111
yagirei@juntendo.ac.jp
Juntendo University School of Medicine
none
Self funding
NO
2013 | Year | 12 | Month | 04 | Day |
Unpublished
No longer recruiting
2013 | Year | 11 | Month | 22 | Day |
2013 | Year | 12 | Month | 04 | Day |
2013 | Year | 12 | Month | 04 | Day |
2016 | Year | 01 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014621
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