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

NCT02303873 | Completed Phase 4

• 1 other identifier: No. 2007-03-12
• Study Type: interventional
• Target: 99
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteogenesis Imperfecta

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• changes of bone turnover biomarkers

  baseline and 6,12,24,36 months

• changes of height

  baseline and 12,24,36 months

Study Arms (1)

an open label, prospective, self-controlled study

EXPERIMENTAL

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).

Drug: Alendronate

Interventions

Alendronate DRUG

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

an open label, prospective, self-controlled study

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• children or adolescents aged 0-18 years,
• 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;
• with or without blue sclera, impaired hearing, joint hypermobility or dentinogenesis imperfecta;
• with or without slim long bone; with or without cranial epactal bones, signs of multiple fractures, bony deformity in skeletal X-ray films.

You may not qualify if:

• previous history of rickets, hyperparathyroidism, other metabolic or inherited bone diseases; malignant disease; coeliac disease; hyperthyroidism;
• therapy history of BPs within recent two years; severe renal failure (creatinine clearance \<40 ml/min), chronic liver disease; severe diseases of gastrointestinal tract;
• unable to keep upright for at least 30 minutes daily .

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• National Natural Science Foundation of China: collaborator

MeSH Terms

Conditions

Osteogenesis Imperfecta

Interventions

Alendronate

Condition Hierarchy (Ancestors)

Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2014
• First Posted: December 1, 2014
• Study Start: March 1, 2007
• Primary Completion: July 1, 2011
• Study Completion: August 1, 2014
• Last Updated: December 10, 2014

Record last verified: 2014-11