Efficacy and Safety of Alendronate in Chinese Children or Adolescents With Osteogenesis Imperfecta

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborator: National Natural Science Foundation of China
• Treatments: Alendronate

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 .