UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002457 |
|---|---|
| Receipt number | 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 13:12:44 |
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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
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
Sponsor or person
Institute
University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003009
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| Registered date | File name |
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| Registered date | File name |
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