UMIN-CTR Clinical Trial

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
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IRB Contact (For public release)
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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
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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
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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
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