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Efficacy and Safety of Alendronate in Chinese Children or Adolescents With Osteogenesis Imperfecta | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

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

NCT02303873•Peking Union Medical College Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - 18 years

Sex

ALL

Healthy Volunteers

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 .

Key Dates

Start Date

March 1, 2007

Primary Completion Date

July 1, 2011

Completion Date

August 1, 2014

Last Updated

December 10, 2014

Enrollment

ACTUAL participants

Conditions

Osteogenesis Imperfecta

Interventions

Alendronate

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 10, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Effects of Bisphosphonates on OI-Related Hearing Loss

Cardiopulmonary Outcomes in Osteogenesis Imperfecta: BBD7708

Boost Brittle Bones Before Birth

Evaluation and Intervention for the Effects of Osteogenesis Imperfecta

Mesenchymal Cell Therapy in Osteogenesis Imperfecta (OI)

Treatment of Osteogenesis Imperfecta With Parathyroid Hormone and Zoledronic Acid