UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001082 |
|---|---|
| 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 |
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Basic information
Public 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
Acronym
A randomized prospective study to compare the efficacy and safety between once-weekly and daily alendronate therapy in patients with corticosteroid-induced osteoporosis
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
Scientific Title:Acronym
A randomized prospective study to compare the efficacy and safety between once-weekly and daily alendronate therapy in patients with corticosteroid-induced osteoporosis
Region
| Japan |
Condition
Condition
Corticosteroid-induced osteoporosis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
safety/ efficacy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Mean percent change in bone mineral density (BMD) of lumbar spine at 48 weeks
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Once-weekly group: receive 35mg of alendronate once a week for 52 weeks
Interventions/Control_2
Daily group: receive 5mg of alendronate daily for 52 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
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.
Key exclusion criteria
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.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinji Sato |
Organization
Keio University School of Medicine
Division name
Internal Medicine
Zip code
Address
35 Shinanomachi Shinjuku-ku Tokyo
TEL
03-3353-1211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinji Sato |
Organization
Keio University School of Medicine
Division name
Internal Medicine
Zip code
Address
35 Shinanomachi Shinjuku-ku Tokyo
TEL
03-3353-1211
Homepage URL
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Teijin Pharmaceuticals
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2008 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 03 | Month | 18 | Day |
Last modified on
| 2011 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001313
