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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||||||
Condition | glucocorticoid-induced osteoporosis | |||||
Classification by specialty |
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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 |
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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 | ||
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Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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) |
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Target sample size | 200 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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) | |
Organization | |
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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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Progress | |||||||
Recruitment status | Preinitiation | ||||||
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Last modified on |
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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 |