UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004217 |
|---|---|
| Receipt number | R000005067 |
| Scientific Title | Combination therapy with alendronate and alphacalcidol for prevention of symptomatic vertebral fracture in elderly patients treated with high-dose glucocorticoid: a multicenter open-label randomized controlled trial. |
| Date of disclosure of the study information | 2010/10/01 |
| Last modified on | 2010/09/15 20:54:42 |
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Basic information
Public title
Combination therapy with alendronate and alphacalcidol for prevention of symptomatic vertebral fracture in elderly patients treated with high-dose glucocorticoid: a multicenter open-label randomized controlled trial.
Acronym
ALIS study
Scientific Title
Combination therapy with alendronate and alphacalcidol for prevention of symptomatic vertebral fracture in elderly patients treated with high-dose glucocorticoid: a multicenter open-label randomized controlled trial.
Scientific Title:Acronym
ALIS study
Region
| Japan |
Condition
Condition
glucocorticoid-induced osteoporosis
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Clinical immunology |
| Geriatrics | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of alphacalcidol for prevention of symptomatic vertebral fracture in elderly patients treated with alendronate in glucocorticoid-induced osteoporosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Symptomatic vertebral fractures, those are determined by conventional thoracic and spinal radiographs in lateral and antero-posterior projections at any time during study.
Key secondary outcomes
Non symptomatic vertebral fractures, those are determined by conventional thoracic and spinal radiographs in lateral and antero-posterior projections at 0, 6, 12, 24 months.
Bone mineral density values, those are measured at the lumbar spine on day 0 and at 6, 12, 24 months.
The serum levels of NTX, osteocalcin, 25(OH)vitamin D, growth hotmone, IGF-, those are measured on days 0, 7 and at 1, 3, 6, 12 months after glucocorticoid treatment.
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
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Alendronate group: receive alendronate 35mg once a week for 96 weeks
Interventions/Control_2
Alendronate + Alfacalcidol group: receive alendronate 35mg once a week + alfacalcidol 1 (0.5) microgram/day for 96 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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are initially treated with more than 10 mg/day glucocorticoid (prednisolone) for more than 3 months or scheduled to be treated for more than 3 months.
Key exclusion criteria
1)Patient who was not treated for more than 6 months (except, who had symptomatic vertebral fractures).
2)Patient who has serious renal disorder (EGFR: <35ml or Cre: more than 1.5mg/ml).
3)Patient who has a history of renal stone past 5 years.
4)Patient with primary or secondary hyperparathyroidism.
5)Patient with hyperthyroidism or hypothyroidism.
6)Patients who is diagnosed as contraindication of alendronate treatements or Alfacalcidol.
7)Patient who are treated with warfarin.
8)Patient who is inappropriate for this study by physician.
9)Patient who has experiences of receiving bisphosphonate treatment within 6 months at inclusion of the study.
10)Patient who has experiences of receiving drugs having influence on bone remodeling within 6 months at inclusion of the study (Estrogen, Vitamin D, Calcitonin, Raloxifene, Ipriflavone, Vitamin K, Steroid)
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takao Sugiyama |
Organization
National Hospital Organization Shimoshizu National Hospital
Division name
Department of Rheumatology
Zip code
Address
Shikawata 934-5, Yotsukaido-city, Chiba, Japan
TEL
043-452-2511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ichiro Tatsuno |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Clinical Cell Biology
Zip code
Address
1-8-1, Inohana-cho, Chuou-ku, Chiba-city, Japan
TEL
043-222-7171
Homepage URL
ichiro-tatsuno@faculty.chiba-u.jp
Sponsor or person
Institute
Society for glucocorticoid-induced osteoporosis
Institute
Department
Personal name
Funding Source
Organization
Foundation for Advancement of International Science
Organization
Division
Category of Funding Organization
Non profit foundation
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
国立病院機構 下志津病院（千葉県）
千葉大学医学部附属病院（千葉県）
国立病院機構 千葉東病院（千葉県）
国保松戸市立病院（千葉県）
獨協医科大学医学部付属病院（栃木県）
上都賀総合病院（栃木県）
国立病院機構 相模原病院（神奈川県）
埼玉医科大学総合医療センター（埼玉県）
JFE川鉄千葉病院（千葉県）
亀田総合病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | 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
Preinitiation
Date of protocol fixation
| 2010 | Year | 07 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 09 | Month | 15 | Day |
Last modified on
| 2010 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005067
