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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002457
Receipt No. R000003009
Scientific Title Early diagnosis and early intervention by alendronate of glucocorticoid-induced osteoporosis in patients who are initially treated with glucocorticoid
Date of disclosure of the study information 2009/09/06
Last modified on 2012/03/06

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Basic information
Public title Early diagnosis and early intervention by alendronate of glucocorticoid-induced osteoporosis in patients who are initially treated with glucocorticoid
Acronym Early DIagnosis and Treatment of OsteopoRosis in Japan (EDITOR-J)
Scientific Title Early diagnosis and early intervention by alendronate of glucocorticoid-induced osteoporosis in patients who are initially treated with glucocorticoid
Scientific Title:Acronym Early DIagnosis and Treatment of OsteopoRosis in Japan (EDITOR-J)
Region
Japan

Condition
Condition Connective tissue diseases
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Glucocorticoid-induced osteoporosis is induced in patients with connective tissue diseases who are treated with glucocorticoid, whose population is thought to be about 2 million in Japan. However, early diagnosis and early intervention remain unclear. In this study we clarify the following issues; 1) early diagnosis of change of bone metabolism by bone marker proteins just after the initiation of glucocorticoid therapy, 2) correlation of the early diagnosis of the bone metabolism and bone mineral density and fracture by the longitudinal observation, 3) clinical efficacy of early intervention by alendronate in patients who are treated with glucocorticoid.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1) Changes of bone metabolism markers at one week after the initiation of glucocorticoid therapy
2) Changes of bone metabolism at six months after the early intervention by alendronate in patients initially treated with glucocorticoid

Key secondary outcomes 1) Change of bone metabolism markers at 6 months after the initiation of glucocorticoid therapy
2) Correlation of the changes of bone markers at one week after the treatment with the changes of bone metabolism at six months after the treatement

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Glucocorticoid + alfacalcidol 1 (0.5) microgram/day
Interventions/Control_2 Glucocorticoid + alendronate 35 mg/week
Interventions/Control_3 Glucocorticoid + alfacalcidol 1 (0.5) microgram/day + alendronate 35 mg/week
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
18 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Patients who are diagnosed as connective tissue diseases and are initially treated with more than 20 mg/day glucocorticoid (prednisolone)
Key exclusion criteria 1) female who are pregnant
2) male
3) patients who are already diagnosed as osteoporosis
4) patients who are already treated with glucocorticoid
5) patients who are already treated with bisphosphonate
6) patients diagnosed as esophageal narrowing or esophageal achalasia
7) patients who cannot stand or sit for more than 30 minutes
8) patients sensitive to bisphosphonates
9) patients with hypocalcemia
10) patients who are not appropriate to the study by a doctor's judgement
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiya Tanaka
Organization School of Medicine, University of Occupational and Environmental Health, Japan
Division name First Department of Internal Medicine
Zip code
Address 1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, 807-8555, Japan
TEL 093-603-1611
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yosuke Okada
Organization School of Medicine, University of Occupational and Environmental Health, Japan
Division name First Department of Internal Medicine
Zip code
Address 1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, 807-8555, Japan
TEL 093-603-1611
Homepage URL
Email

Sponsor
Institute University of Occupational and Environmental Health, Japan
Institute
Department

Funding Source
Organization A Research Grant-In-Aid for Scientific Research from the Ministry of Health, Labor and Welfare of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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
2009 Year 09 Month 06 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 Enrolling by invitation
Date of protocol fixation
2007 Year 02 Month 24 Day
Date of IRB
Anticipated trial start date
2007 Year 06 Month 01 Day
Last follow-up date
2010 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 09 Month 06 Day
Last modified on
2012 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003009

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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