Unique ID issued by UMIN | UMIN000040956 |
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Receipt number | R000046770 |
Scientific Title | Effect of a monoclonal antibody to sclerostin (romosozumab) on dialysis patients with osteoporosis |
Date of disclosure of the study information | 2020/09/01 |
Last modified on | 2024/02/15 12:48:53 |
Effect of a monoclonal antibody to sclerostin (romosozumab) on dialysis patients with osteoporosis
Effect of romosozumab on dialysis patients with osteoporosis
Effect of a monoclonal antibody to sclerostin (romosozumab) on dialysis patients with osteoporosis
Effect of romosozumab on dialysis patients with osteoporosis
Japan |
Chronic renal failure
Nephrology |
Others
NO
To clarify the effect of romosozumab on osteoporosis in dialysis patients
Safety,Efficacy
Radial bone density (distal 1/3, distal 1/10), bone metabolism-related markers [calcium, phosphorus, parathyroid hormone, alkaline phosphatase, bone-type alkaline phosphatase (BAP), osteocalcin (OC), I type procollagen-N-propeptide (P1NP), tartrate-resistant acid phosphatase-5b (TRACP-5b)]
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Treatment
Medicine |
Intramuscularly administer 210 mg of romosozumab once a month
20 | years-old | <= |
90 | years-old | > |
Female
A female dialysis patient attending our hospital with osteoporosis whose radial bone density is less than 70% based on the YAM value.
Patients complicated with serious diseases such as malignancy, heart failure (NYHA III degrees or more), and liver cirrhosis
10
1st name | Michio |
Middle name | |
Last name | Kuwahara |
Saitama Tsukinomori Clinic
Division of Nephrology
339-0012
366-1 Mashinaga, Iwatsuki-ku, Saitama city, Saitama 339-0012, Japan
0487921811
kuwahara@k-naika-cl.jp
1st name | Michio |
Middle name | |
Last name | Kuwahara |
Saitama Tsukinomori Clinic
Division of Nephrology
339-0012
366-1 Mashinaga, Iwatsuki-ku, Saitama city, Saitama 339-0012, Japan
0487921811
kuwahara@k-naika-cl.jp
Saitama Tsukinomori Clinic
Saitama Tsukinomori Clinic
Self funding
the ethics committee of Saitama Tsukinomori Clinic
366-1 Mashinaga, Iwatsuki-ku, Saitama city, Saitama 339-0012, Japan
0487921811
hayama@k-naika-cl.jp
NO
2020 | Year | 09 | Month | 01 | Day |
Unpublished
6
BAP, OC, and P1NP significantly increased after romosozumab administration. No significant change was observed in TRACP-5b. There were no significant changes in the YAM values of the distal 1/3 and 1/10 of the radius.
2024 | Year | 02 | Month | 15 | Day |
Completed
2020 | Year | 06 | Month | 01 | Day |
2020 | Year | 06 | Month | 23 | Day |
2021 | Year | 12 | Month | 01 | Day |
2023 | Year | 10 | Month | 31 | Day |
2023 | Year | 11 | Month | 15 | Day |
2023 | Year | 11 | Month | 15 | Day |
2024 | Year | 02 | Month | 01 | Day |
The main results of this study are as follows. 1. The BAP value significantly increased from 18.9+3.0 (SE, IU/L) before romosozumab administration to 35.6+6.0 1 month later, and the significant increase continued until 3 months later. The OC value significantly increased from 161+28 (ng/mL) before administration to 238+36 1 month later, and the significant increase continued until 3 months later. The P1NP value significantly increased from 472+134 (ng/mL) before administration to 714+146 one month later. The TRACP-5b value increased from 816+91 (mU/dL) before administration in 3 patients and decreased in 3 patients, so no significant changes were observed. 2. YAM values in the distal third of the radius increased in 2 patients but decreased in 4 patients, so no significant change was observed. The YAM value at the distal 1/10 of the radius also increased in 2 patients and decreased in 4 patients, so there was no significant change. The change in YAM value in the distal third region improved from -3.33+4.45%/year one year before administration to -1.33+1.75%/year one year after administration. In addition, the distal 1/10 region also improved from -6.5+9.95%/year to -0.83+4.95%. As described above, romosozumab was considered to promote bone formation based on bone metabolism markers, but no effect on bone resorption was observed. For the radius, romosozumab had an effect of suppressing the decrease in YAM values, but had no effect on improving YAM values.
The summary of this study was presented at the 66th Annual Meeting of the Japanese Society of Dialysis Therapy (Yokohama, June 2021) and the 67th Annual Meeting of the Japanese Society of Dialysis Therapy (Yokohama, July 2022).
2020 | Year | 06 | Month | 30 | Day |
2024 | Year | 02 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046770
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