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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001082
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Keio University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001313

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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