Status:
COMPLETED
Efficacy and Safety of Alendronate in Chinese Children or Adolescents With Osteogenesis Imperfecta
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
National Natural Science Foundation of China
Conditions:
Osteogenesis Imperfecta
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE4
Brief 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 incid...
Eligibility Criteria
Inclusion
- children or adolescents aged 0-18 years,
- 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;
- with or without blue sclera, impaired hearing, joint hypermobility or dentinogenesis imperfecta;
- with or without slim long bone; with or without cranial epactal bones, signs of multiple fractures, bony deformity in skeletal X-ray films.
Exclusion
- previous history of rickets, hyperparathyroidism, other metabolic or inherited bone diseases; malignant disease; coeliac disease; hyperthyroidism;
- therapy history of BPs within recent two years; severe renal failure (creatinine clearance \<40 ml/min), chronic liver disease; severe diseases of gastrointestinal tract;
- unable to keep upright for at least 30 minutes daily .
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT02303873
Start Date
March 1 2007
End Date
August 1 2014
Last Update
December 10 2014
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