Unique ID issued by UMIN | UMIN000019874 |
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Receipt number | R000022923 |
Scientific Title | The Effect of Rsedronate and Denosumab on Periprosthetic Bone Remodeling Following Total Hip Arthroplasty |
Date of disclosure of the study information | 2015/11/20 |
Last modified on | 2020/12/22 09:44:39 |
The Effect of Rsedronate and Denosumab on Periprosthetic Bone Remodeling Following Total Hip Arthroplasty
Prevention of stress shielding with risedoronate and denosumab
The Effect of Rsedronate and Denosumab on Periprosthetic Bone Remodeling Following Total Hip Arthroplasty
Prevention of stress shielding with risedoronate and denosumab
Japan |
Osteoarthritis of the hip
Orthopedics |
Others
NO
To evaluate efficacy of Rsedronate and Denosumab on Periprosthetic Bone Remodeling Following Total Hip Arthroplasty
Safety,Efficacy
Exploratory
Pragmatic
The percentage change in periprosthetic bone mineral density
The change in bone mineral density of the vertebra, The percentage change in bone metabolic markers of resorption and formation, Harris Hip Score, Periprosthetic X-ray change
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
NO
Central registration
2
Treatment
Medicine |
subcutaneous injection denosumab, 60mg every 6 months use for 2 years
oral risedronate, 17.5mg once weekly, use for 2 years
60 | years-old | <= |
80 | years-old | > |
Male and Female
1) Osteoarthritis of the hip
2) Young Adult Mean< 80% / Proximal femur or Lumbar vertebra
1) oral Bisphosphonate therapy for more than 3 years
2) oral Bisphosphonate therapy within 6 months prior to the study enrollment
3) oral Bisphosphonate therapy for more than 2 weeks between 6 months and 3 years prior to the study enrollment
4) intravenous Bisphosphonate therapy within 5 years prior to the study enrollment
5) Parathyroid hormone therapy within 6 weeks prior to the study enrollment
6) A history of Osteotomy
7) sever renal dysfunction (GFR< 30)
8) sever liver dysfunction
9) malignant tumor
10) hypocalcemia, hypokalemia
11) A history ofesophagostenosis, esophageal achalasia
12) A history of hyperparathyroidism
13) glucocorticoids therapy
14) pregnant woman
15) The patients should be excluded, who have poor medical compliance, drug-induced allergy, etc.
100
1st name | Kazuo |
Middle name | |
Last name | Hirakawa |
Shonan Kamakura Joint Reconstruction Center
Department of Orthopedic
247-0061
5-4-17 Dai,Kamakura,Kanagawa
0466-47-2377
mail@skjrc.jp
1st name | Nariaki |
Middle name | |
Last name | Nakura |
Shonan Kamakura Joint Reconstruction Center
Department of Orthopedic
247-0061
5-4-17 Dai, Kamakura, Kanagawa
0466-47-2377
izumi.kokubun@tokushukai.jp
Shonan Kamakura Joint Reconstruction Center
None
Self funding
None
None
Mirai Iryo Research Center
1-8-7, Koji-machi, Chiyoda-ku, Tokyo 102-0083, Japan
0332634801
mirai-ec1@mirai-iryo.com
NO
医療法人沖縄徳洲会 湘南鎌倉人工関節センター
(Shonan Kamakura Joint Reconstruction Center)
2015 | Year | 11 | Month | 20 | Day |
Unpublished
Completed
2015 | Year | 09 | Month | 15 | Day |
2015 | Year | 09 | Month | 15 | Day |
2015 | Year | 11 | Month | 24 | Day |
2020 | Year | 09 | Month | 30 | Day |
2015 | Year | 11 | Month | 20 | Day |
2020 | Year | 12 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022923
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