Unique ID issued by UMIN | UMIN000011992 |
---|---|
Receipt number | R000014017 |
Scientific Title | Efficacy and safety of denosumab for the treatment of osteoporosis in patients with renal failure |
Date of disclosure of the study information | 2013/10/08 |
Last modified on | 2019/04/13 10:50:42 |
Efficacy and safety of denosumab for the treatment of osteoporosis in patients with renal failure
Efficacy and safety of denosumab for the treatment of osteoporosis in patients with renal failure
Efficacy and safety of denosumab for the treatment of osteoporosis in patients with renal failure
Efficacy and safety of denosumab for the treatment of osteoporosis in patients with renal failure
Japan |
Osteoporosis
Endocrinology and Metabolism | Nephrology |
Others
NO
The aim of this study is to clarify the safety and efficacy of denosumab for the treatment of osteoporosis in patients with renal dysfunction.
Safety,Efficacy
Exploratory
Pragmatic
Change of bone mineral density (BMD) at lumbar supine and femoral neck
Side effect, rate of continuation, change of bone metabolic markers, and serum calcium.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
60 mg of denosumab s.c every 6 months
20 | years-old | <= |
Not applicable |
Male and Female
CKD patients (eGFR<60 ml/min) with osteoporosis (T score <2.5).
CKD patients with corrected calcium (cCa)<8.5 mg/dl or serum PTH> 110 pg/ml.
Patients with dialysis whose serum Ca, P, and PTH are out of the range recommended by JSDT 2012 (cCa 8.5-10.0 mg/dl, P 3.5-6.0 mg/dl, and PTH 60-240 pg/ml)
40
1st name | |
Middle name | |
Last name | Kenmei Takaichi |
Toranomon Hospital
Nephrology Center
2-2-2, Toranomon, Minato-ku, Tokyo
03-3588-1111
takaichi-tky@umin.ac.jp
1st name | |
Middle name | |
Last name | Junichi Hoshino |
Toranomon Hospital Kajigaya
Nephrology Center
1-3-1, Kajigaya, Takatsu-ku, Kawasaki, Kanagawa
044-877-5111
jhoshino-ind@umin.ac.jp
Nephrology Center, Toranomon Hospital
Nephrology Center, Toranomon Hospital Kajigaya
None
Self funding
NO
虎の門病院(東京都)、虎の門病院分院(神奈川県)
2013 | Year | 10 | Month | 08 | Day |
Partially published
Completed
2013 | Year | 08 | Month | 01 | Day |
2013 | Year | 08 | Month | 01 | Day |
2013 | Year | 08 | Month | 01 | Day |
2018 | Year | 10 | Month | 11 | Day |
2018 | Year | 10 | Month | 11 | Day |
2013 | Year | 10 | Month | 08 | Day |
2019 | Year | 04 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014017