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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000004217
Receipt No. 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

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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
Email

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
Email ichiro-tatsuno@faculty.chiba-u.jp

Sponsor
Institute Society for glucocorticoid-induced osteoporosis
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005067

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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