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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02303873 |
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Date of registration:
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19/11/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of Alendronate in Chinese Children or Adolescents With Osteogenesis Imperfecta
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Scientific title:
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Efficacy and Safety of Alendronate in Chinese Children or Adolescents With Osteogenesis Imperfecta: an Age Stratified Prospective Study |
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Date of first enrolment:
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March 2007 |
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Target sample size:
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99 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02303873 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. children or adolescents aged 0-18 years,
2. had either a history of at least once minor-impact fracture or age and sex adjusted
areal BMD Z score of -1.0 or less at lumbar spine or total hip;
3. with or without blue sclera, impaired hearing, joint hypermobility or dentinogenesis
imperfecta;
4. with or without slim long bone; with or without cranial epactal bones, signs of
multiple fractures, bony deformity in skeletal X-ray films.
Exclusion Criteria:
1. previous history of rickets, hyperparathyroidism, other metabolic or inherited bone
diseases; malignant disease; coeliac disease; hyperthyroidism;
2. therapy history of BPs within recent two years; severe renal failure (creatinine
clearance <40 ml/min), chronic liver disease; severe diseases of gastrointestinal
tract;
3. unable to keep upright for at least 30 minutes daily .
Age minimum:
N/A
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Osteogenesis Imperfecta
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Intervention(s)
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Drug: Alendronate
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Primary Outcome(s)
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changes from baseline of areal BMD at lumbar spine and total hip
[Time Frame: baseline and 12,24,36 months]
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annual clinical fracture incidence
[Time Frame: baseline and 12,24,36 months]
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Secondary Outcome(s)
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changes of height
[Time Frame: baseline and 12,24,36 months]
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changes of bone turnover biomarkers
[Time Frame: baseline and 6,12,24,36 months]
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Secondary ID(s)
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No. 2007-03-12
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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