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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


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 hip

annual clinical fracture incidence

Secondary outcome:

changes of bone turnover biomarkers

changes of height


Minimum age: N/A. Maximum age: 18 Years. Gender(s): Both.


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

Page last updated: August 20, 2015

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