Efficacy and Safety of Alendronate in Chinese Children or Adolescents With Osteogenesis Imperfecta
Information source: Peking Union Medical College Hospital
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteogenesis Imperfecta
Intervention: Alendronate (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Peking Union Medical College Hospital
Summary
Alendronate should be considered as an alternative therapy of osteogenesis imperfecta (OI)
because it significantly increased areal bone mineral density (BMD) and its Z score,
decreased fracture incidence, inhibited bone resorption biomarkers. Alendronate exerted
beneficial roles in different age brackets, especially in young patients with OI.
Clinical Details
Official title: Efficacy and Safety of Alendronate in Chinese Children or Adolescents With Osteogenesis Imperfecta: an Age Stratified Prospective Study
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: changes from baseline of areal BMD at lumbar spine and total hipannual clinical fracture incidence
Secondary outcome: changes of bone turnover biomarkerschanges of height
Eligibility
Minimum age: N/A.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
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 .
Locations and Contacts
Additional Information
Starting date: March 2007
Last updated: December 9, 2014
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