Unique ID issued by UMIN | UMIN000015573 |
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Receipt number | R000018098 |
Scientific Title | Fracture inhibitory effect verification test of osteoporosis drug for primary osteoporosis patients at high risk of fracture |
Date of disclosure of the study information | 2014/11/01 |
Last modified on | 2021/06/01 11:08:23 |
Fracture inhibitory effect verification test of osteoporosis drug for primary osteoporosis patients at high risk of fracture
A-TOP/JOINT-05
Fracture inhibitory effect verification test of osteoporosis drug for primary osteoporosis patients at high risk of fracture
A-TOP/JOINT-05
Japan |
Osteoporosis
Medicine in general | Endocrinology and Metabolism | Obstetrics and Gynecology |
Orthopedics |
Others
NO
The head-to-head comparison of once
weekly teriparatid and alendronate
Safety,Efficacy
Confirmatory
Pragmatic
Phase IV
Incidence of new vertebral fracture
at 72 weeks
Incidence of new vertebral fracture and non-vertebral fracture at 72 and 120 weeks
Incidence of new vertebral fracture
Exacerbation of vertebral fracture incidence
BMD rate of change
QOL rate of change
Bone structure analysis
Interventional
Parallel
Randomized
Cluster
Open -no one is blinded
Active
YES
Institution is considered as adjustment factor in dynamic allocation.
Central registration
2
Treatment
Medicine | Food |
once weekly teriparatide
alendronate
75 | years-old | <= |
Not applicable |
Female
A document agreement of the clinical study participation is provided and intends for a patient meeting all the following standards
1.Primary osteoporosis
2.a Japanese patient 75 years or older
3.postmenopausal women
4.The patient that an independence walk is possible
5.The patient who satisfies any of the following
Patient with less than in bone density 60% of YAM or less than -3.3SD
The patient who has vertebral body bone fractures more than two to the fourth lumbar vertebrae from the fourth thoracic vertebra at the time of registration
Patient having a bone fracture of grade 3
The patient who has the past of the proximal thighbone bone fracture
1.Secondary osteoporosis
2.bone loss Disease other than osteoporosis
3.diseases that affect the strength of the vertebral body
4.hypersensitivity
5.use of contraindicated therapeutic drugs
6.severe complications such as heart disease, liver disease, renal disease
7.problem with the reliability of the interview data
8.inpatient
9.Patients treated with teriparatide in the past
1000
1st name | Satoshi |
Middle name | |
Last name | Mori |
Seirei Hamamatsu General Hospital
chief department of Bone&Joint and Orthopaedic surgery
4308558
2-12-12Sumiyoshi,Chuo-ku,Hamamtsu,Shizuoka
053-474-2222
stmori@sis.seirei.or.jp
1st name | Yoji |
Middle name | |
Last name | Mitadera |
Public Health Research Foundation
Comprehensive Support Project for
1690051
1-1-7Nishiwaseda,Shinjuku-ku,Tokyo,japan
03-5287-2638
http://www.a-top.jp
a-top@csp.or.jp
Research committee of A-TOP
Public Health Research Foundation
Non profit foundation
Japan
-
-
-
-
NO
2014 | Year | 11 | Month | 01 | Day |
Unpublished
Completed
2014 | Year | 09 | Month | 29 | Day |
2014 | Year | 10 | Month | 06 | Day |
2014 | Year | 11 | Month | 04 | Day |
2020 | Year | 05 | Month | 30 | Day |
2020 | Year | 07 | Month | 31 | Day |
2020 | Year | 10 | Month | 31 | Day |
2020 | Year | 12 | Month | 29 | Day |
2014 | Year | 10 | Month | 31 | Day |
2021 | Year | 06 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018098
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