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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004188
Receipt No. R000005030
Scientific Title A prospective, randomized controlled trial comparing alendronate and alendronate plus alphacalcidol therapy in patients with steroid-induced osteoporosis accompanied with interstitial pneumonias
Date of disclosure of the study information 2010/09/10
Last modified on 2014/09/10

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Basic information
Public title A prospective, randomized controlled trial comparing alendronate and alendronate plus alphacalcidol therapy in patients with steroid-induced osteoporosis accompanied with interstitial pneumonias
Acronym Steroid-induced osteoporosis accompanied with interstitial pneumonias
Scientific Title A prospective, randomized controlled trial comparing alendronate and alendronate plus alphacalcidol therapy in patients with steroid-induced osteoporosis accompanied with interstitial pneumonias
Scientific Title:Acronym Steroid-induced osteoporosis accompanied with interstitial pneumonias
Region
Japan

Condition
Condition interstitial pneumonias
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects and the safety of alendronate and alendronate plus alphacalcidol therapy in patients with steroid-induced osteoporosis accompanied with interstitial pneumonias
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes (1) The change in the lumbar-spine bone mineral density from baseline
(2) The change in the markers of of bone metabolism from baseline
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 alendronate
Interventions/Control_2 alendronate plus alphacalcidol
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
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria The patients who was expected to treat with oral prednisolone 30mg/day at least for a week and continued with 5mg/day of prednisolone at least for three months for the therapy of interstitial pneumonias
Key exclusion criteria (1) The patients who have severe complications
(2) The patients who have the diseases of bone metabolism
(3) The patients who were administered steroid therapy within a year
(4) The patients who are administered therapy affecting bone metabolism
(5) The patients who have fracture or scoliosis at 3rd to 5th lumbar
(6) The patients who have impaired renal function (Cr > 1.5mg/dl)
(7) The patients who are contraindicated to take alendronate or alphacalcidol
(8) The patients who are pregnant
(9) The patients who attended clinical trials within three months
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeru Kohno
Organization Nagasaki University School of Medicine
Division name Second Department of Internal Medicine
Zip code
Address 1-7-1 Sakamoto, Nagasaki, Japan
TEL 095-819-7273
Email nsakamot@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriho Sakamoto
Organization Nagasaki University Hospital
Division name Second Department of Internal Medicine
Zip code
Address 1-7-1 Sakamoto, Nagasaki, Japan
TEL 095-819-7273
Homepage URL
Email nsakamot@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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
2010 Year 09 Month 10 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 No longer recruiting
Date of protocol fixation
2008 Year 01 Month 17 Day
Date of IRB
Anticipated trial start date
2008 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 09 Month 10 Day
Last modified on
2014 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005030

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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