Unique ID issued by UMIN | UMIN000001082 |
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Receipt number | R000001313 |
Scientific Title | A randomized open-label blinded prospective study designed to compare the efficacy and safety between once-weekly and daily administration of alendronate in patients with corticosteroid-induced osteoporosis |
Date of disclosure of the study information | 2008/04/01 |
Last modified on | 2011/09/23 08:20:15 |
A randomized open-label blinded prospective study designed to compare the efficacy and safety between once-weekly and daily administration of alendronate in patients with corticosteroid-induced osteoporosis
A randomized prospective study to compare the efficacy and safety between once-weekly and daily alendronate therapy in patients with corticosteroid-induced osteoporosis
A randomized open-label blinded prospective study designed to compare the efficacy and safety between once-weekly and daily administration of alendronate in patients with corticosteroid-induced osteoporosis
A randomized prospective study to compare the efficacy and safety between once-weekly and daily alendronate therapy in patients with corticosteroid-induced osteoporosis
Japan |
Corticosteroid-induced osteoporosis
Clinical immunology |
Others
NO
safety/ efficacy
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Mean percent change in bone mineral density (BMD) of lumbar spine at 48 weeks
Mean percent change in BMD of lumbar spine at 24 weeks
Mean percent change in BMD of femur trochanter and distal radius at 24 and 48 weeks
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Medicine |
Once-weekly group: receive 35mg of alendronate once a week for 52 weeks
Daily group: receive 5mg of alendronate daily for 52 weeks
16 | years-old | <= |
Not applicable |
Male and Female
Patients who are seeing in out patient clinic or hospitalized in Keio University Hospital. Patients who take more than 5 mg daily dose of prednisolone.Patients who can understand the aim of this study and consent to participate in this study.
Patients who take other medicine affected with bone metabolism (other bisphosphonates, calcitonin, vitamin D derivatives, ipriflavone, estrogen derivatives, menaquinones, Raloxifene hydrochloride) within twelve weeks.Patients who have allergic reaction to bisphosphonates.Patients who have esophageal stenosis or akalasia. Patients who cannot keep a sitting position more than 30 minutes.Patients who have sever renal, liver, cardiac dysfunction or hematological disorders. Patients who have metabolic disorders.Patients who have neoplasm.Patients who have hypocarcemia or hypercarcemia.Patients who are pregnant.Patients who are considered to inappropriate to join to this study.
130
1st name | |
Middle name | |
Last name | Shinji Sato |
Keio University School of Medicine
Internal Medicine
35 Shinanomachi Shinjuku-ku Tokyo
03-3353-1211
1st name | |
Middle name | |
Last name | Shinji Sato |
Keio University School of Medicine
Internal Medicine
35 Shinanomachi Shinjuku-ku Tokyo
03-3353-1211
Keio University
Teijin Pharmaceuticals
Profit organization
NO
2008 | Year | 04 | Month | 01 | Day |
Unpublished
Terminated
2008 | Year | 03 | Month | 10 | Day |
2008 | Year | 03 | Month | 01 | Day |
2011 | Year | 03 | Month | 01 | Day |
2011 | Year | 04 | Month | 01 | Day |
2011 | Year | 06 | Month | 01 | Day |
2011 | Year | 08 | Month | 01 | Day |
2008 | Year | 03 | Month | 18 | Day |
2011 | Year | 09 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001313
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