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Completed

NCT Number: NCT02303873

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

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.

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Key information

Conditions

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

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 .

Treatment and study plan

Alendronate

Drug

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

Primary outcomes

  1. changes from baseline of areal BMD at lumbar spine and total hip

    Time frame: baseline and 12,24,36 months

  2. annual clinical fracture incidence

    Time frame: baseline and 12,24,36 months

Secondary outcomes

  1. changes of bone turnover biomarkers

    Time frame: baseline and 6,12,24,36 months

  2. changes of height

    Time frame: baseline and 12,24,36 months

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

  • National Natural Science Foundation of China

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2014
First posted
Dec 1, 2014
Registry last updated
Dec 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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