Unique ID issued by UMIN | UMIN000036972 |
---|---|
Receipt number | R000042119 |
Scientific Title | Survey of fractures after discontinuation of denosumab in patients with rheumatoid arthritis. |
Date of disclosure of the study information | 2019/06/07 |
Last modified on | 2022/06/14 14:13:46 |
Survey of fractures after discontinuation of denosumab in patients with rheumatoid arthritis.
Survey of fractures after discontinuation of denosumab in patients with rheumatoid arthritis.
Survey of fractures after discontinuation of denosumab in patients with rheumatoid arthritis.
Survey of fractures after discontinuation of denosumab in patients with rheumatoid arthritis.
Japan |
Rheumatoid arthritis
Clinical immunology | Orthopedics |
Others
NO
Investigate the number of fractures and fracture details after denosumab discontinuation.
Safety
Number and details of fractures after denosumab discontinuation.
None
Observational
Not applicable |
Not applicable |
Male and Female
Preliminary survey
1.Patients who had been received denosumab for at least 1 year while participating in the DESIRABLE.
2.Outpatients who are visiting the same institution as they visited in DESIRABLE.
3.Patients who had a washout period of >7 months between denosumab doses by the date of the preliminary survey.
4.Patients who had not been diagnosed with osteoporosis by the day of 7 months after the last dose of denosumab.Regarding patients with multiple washout periods, ones who had not been diagnosed with osteoporosis by the 7 months after the last dose of denosumab about the first washout period.
Main survey
1.Patients who can give voluntary written informed consent.
2.Patients with development of fracture
in preliminary survey.
None
194
1st name | Hisashi |
Middle name | |
Last name | Nakagaki |
Daiichi Sankyo Co., Ltd.
Medical Science Department
103-8426
1-2-58, Hiromachi, Shinagawa-ku, Tokyo ,Japan
03-6225-1555
nakagaki.hisashi.sh@daiichisankyo.co.jp
1st name | Hideaki |
Middle name | |
Last name | Sainomoto |
Daiichi Sankyo RD Novare Co., Ltd
Clinical Development
140-8710
1-2-58, Hiromachi, Shinagawa-ku, Tokyo ,Japan
03-5436-8542
sainomoto.hideaki.mb@rdn.daiichisankyo.co.jp
Daiichi Sankyo Co., Ltd.
Daiichi Sankyo Co., Ltd.
Profit organization
Clinical research promotion network japan
1-4-9,Itachibori, Nishi-ku, Osaka ,Japan
06-4393-8403
osaka@sct-net.org
NO
2019 | Year | 06 | Month | 07 | Day |
Unpublished
Published
N/A
2
Of the 81 patients in the preliminary survey, 2 patients developed fractures.
2022 | Year | 06 | Month | 14 | Day |
Regarding the two subjects in the fracture survey, both were female and aged 50 and 75 years. Osteoporosis was not a complication in either of the two patients, but the 75-year-old woman had a history of fragility fracture (carpal bone).
The DESIRABLE study allocated 679 patients (94 centers), of which 165 were from pre-study sites (17 centers). Of these, 41 had a diagnosis of osteoporosis at the time of DESIRABLE study entry, and 43 did not meet the study selection criteria, resulting in a total of 81 patients for the feasibility study.
N/A
For the 2 subjects in the fracture survey, fracture #1 was a traumatic left patellar fracture resulting from a fall that occurred 12 months after the last dose of denosumab. Fracture #2 was a symptomatic L1, L2, L4 lumbar compression fracture with low back pain, occurring 13 months after the last dose of denosumab. The patient with fracture #2 was 75 years old and his lumbar spine bone density 5 months prior to fracture was in the region of bone loss with a YAM value of 72%, and he was taking minodronic acid, an osteoporosis drug, at the time of fracture. The bone density of the proximal femur also showed a sharp decrease in YAM value from 88% to 75% before and after the fracture. The outcome of fractures #1 and #2 was recovery and minor injury, respectively.
Completed
2019 | Year | 06 | Month | 03 | Day |
2019 | Year | 05 | Month | 23 | Day |
2019 | Year | 07 | Month | 01 | Day |
2020 | Year | 06 | Month | 30 | Day |
ISSN 0387-4095
2019 | Year | 06 | Month | 05 | Day |
2022 | Year | 06 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042119
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |