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

Osteogenesis Imperfecta Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02303873
• Other study ID #: No. 2007-03-12
• Status: Completed
• Phase: Phase 4
• First received: November 19, 2014
• Last updated: December 9, 2014
• Start date: March 2007
• Est. completion date: August 2014

Study information

• Verified date: November 2014
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: August 2014
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Osteogenesis Imperfecta

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	National Natural Science Foundation of China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes from baseline of areal BMD at lumbar spine and total hip		baseline and 12,24,36 months
Primary	annual clinical fracture incidence		baseline and 12,24,36 months
Secondary	changes of bone turnover biomarkers		baseline and 6,12,24,36 months
Secondary	changes of height		baseline and 12,24,36 months