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

Phase 4

Completed

• Conditions: Osteogenesis Imperfecta
• Interventions: Drug: Alendronate

• Registration Number: NCT02303873
• Lead Sponsor: Peking Union Medical College Hospital

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 incidence, inhibited bone resorption biomarkers. Alendronate exerted beneficial roles in different age brackets, especially in young patients with OI.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2011-07
• Study Completion: 2014-08
• Status Verified: 2014-11
• Study First Submitted: 2014-11-19
• Study First Submitted QC: 2014-11-25
• Study First Posted: 2014-12-01
• Last Update Submitted: 2014-12-09
• Last Update Posted: 2014-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
an open label, prospective, self-controlled study	Alendronate	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).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
changes of bone turnover biomarkers	baseline and 6,12,24,36 months
changes of height	baseline and 12,24,36 months