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

Overview

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.

Full Title of Study: “Efficacy and Safety of Alendronate in Chinese Children or Adolescents With Osteogenesis Imperfecta: an Age Stratified Prospective Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2011

Interventions

  • Drug: Alendronate
    • Alendronate was administrated as 70 mg/week orally (Fosamax, Merck Sharp & Dohme.LTD.).

Arms, Groups and Cohorts

  • Experimental: an open label, prospective, self-controlled study
    • Children or adolescents under the age of 18 years old with minor trauma fracture were recruited from 30 provinces of China. The diagnosis of OI was made by endocrinology department of Peking Union Medical College Hospital(PUMCH).

Clinical Trial Outcome Measures

Primary Measures

  • changes from baseline of areal BMD at lumbar spine and total hip
    • Time Frame: baseline and 12,24,36 months
  • annual clinical fracture incidence
    • Time Frame: baseline and 12,24,36 months

Secondary Measures

  • changes of bone turnover biomarkers
    • Time Frame: baseline and 6,12,24,36 months
  • changes of height
    • Time Frame: baseline and 12,24,36 months

Participating in This Clinical Trial

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 .

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Peking Union Medical College Hospital
  • Collaborator
    • National Natural Science Foundation of China
  • Provider of Information About this Clinical Study
    • Sponsor

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