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 | 2025/09/18 22:55:01 |
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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 | Yoshiya |
| Middle name | |
| Last name | Tanaka |
Organization
School of Medicine, University of Occupational and Environmental Health, Japan
Division name
First Department of Internal Medicine
Zip code
807-8555
Address
1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, 807-8555, Japan
TEL
093-603-1611
tanaka@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Okada |
Organization
School of Medicine, University of Occupational and Environmental Health, Japan
Division name
First Department of Internal Medicine
Zip code
807-8555
Address
1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, 807-8555, Japan
TEL
093-603-1611
Homepage URL
y-okada@med.uoeh-u.ac.jp
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
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Medical Research,University of Occupational and Environmental Health,Japan
Address
1-1 Iseigaoka, Yahatanishiku, Kitakyushu
Tel
093-603-1611
daigakukanri@mbox.pub.uoeh-u.ac.jp
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
https://link.springer.com/article/10.1007/s00774-015-0709-8
Publication of results
Partially published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00774-015-0709-8
Number of participants that the trial has enrolled
106
Results
One week after starting glucocorticoids, patients were randomized to alfacalcidol (1 ug/day, n=33), alendronate (35 mg/week, n=37), or both (n=36). Glucocorticoids caused rapid bone loss within a week. The combination therapy prevented bone loss, increased bone density, and reduced fractures over 12 months.
Results date posted
| 2025 | Year | 09 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study subjects were 106 patients with systemic connective tissue diseases, including 37 SLE, 42 vasculitis syndrome and 27 dermatomyositis/polymyositis. The study comprised 58 premenopausal women and 48 postmenopausal women, with a mean age of 47.8 years; the initial dose of prednisolone was 45.5 mg/day. At baseline, the body mass index was 21.5, BMD for L2-4 was 0.957, and BMD for femoral neck was 0.728.
Participant flow
At the start of the study, blood samples were withdrawn for measurement of various markers of bone metabolism at baseline. No anti-osteoporosis drug was administered within the first week of glucocorticoid therapy. Treatment with glucocorticoid therapy was initiated for 1 week, then the subjects were divided at random into three groups by the sealed envelope method, yielding 34 patients who were treated with 1 ug/day alfacalcidol (vitamin D), 38 patients who received 35 mg/week alendronate, and 38 patients who received alfacalcidol combined with alendronate at the above doses. During the 1-year study, 6 of the alfacalcidol group, 5 of the alendronate group, and 5 of the combination group dropped out due to exacerbation of the present disease or protocol violation. Thus, the study results are based on analysis of data of 28 patients of the alfacalcidol group, 33 patients of the alendronate group, and 33 patients of the combination group. Representative markers of bone metabolism analyzed in the present study included fasting serum C-telopeptides of type I collagen, serum N-telopeptides of type I collagen (NTx), urinary NTx, serum bone alkaline phosphatase, and serum intact parathyroid hormone (PTH). The levels of these markers were measured at baseline before the commencement of glucocorticoid therapy, and at weeks 1 and 24 after the start of therapy.
Adverse events
Severe adverse events including hypercalcemia and withdrawal of the therapies due to adverse events were not reported during the study period. Three patients discontinued the treatment because they were judged unfavorable for continuation.
Outcome measures
The primary endpoints were changes in the value of lumbar spine BMD after 6 months of glucocorticoid therapy and the frequency of bone vertebral fractures at 12 months.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2007 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2007 | Year | 05 | Month | 16 | Day |
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
| 2025 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003009
