Clinical Trials Logo
  1. Home
  2. Osteogenesis Imperfecta
  3. NCT00106028

Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children

Osteogenesis Imperfecta Clinical Trial

Official title:
Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children

Clinical Trial Summary

Children with Osteogenesis Imperfecta (OI) have bone pain, low bone mass and fractures. There are no approved drugs for the treatment of OI in children, even though some intravenous (IV) bisphosphonates are used off-label in some countries. In a single dose, pharmacokinetic study, data showed that risedronate was well tolerated in 28 children with OI. This three year study will test the safety and efficacy of risedronate in the treatment of children with OI. For the first year, patients will be randomized to the risedronate and placebo groups in a 2:1 ratio. For the second and third years of the study, all patients will receive risedronate.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00106028
Study type Interventional
Source Warner Chilcott
Contact
Status Completed
Phase Phase 3
Start date November 2004
Completion date March 2010
View Details
See also
  Status Clinical Trial Phase
Completed NCT03557567 - NGS Strategy Effectiveness in Molecular Diagnosis
Active, not recruiting NCT02531087 - Urinary Biomarkers of OI Pathobiology
Completed NCT01713231 - Effect of High-Dose Vitamin D on Bone Density in Osteogenesis Imperfecta Phase 4
Completed NCT00655681 - Prevention of Post Operative Bone Loss in Children N/A
Recruiting NCT06065111 - Study of Osteogenesis Imperfecta Tendon
Withdrawn NCT03216486 - An Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Phase 2
Recruiting NCT06086613 - A First-in-Human Study Evaluating AGA2115 in Adult Healthy Volunteers Phase 1
Completed NCT04009733 - Epigenetic Regulation of Osteogenesis Imperfecta Severity : miROI Study N/A
Completed NCT04231916 - High Resolution Thermal Imaging to Identify Vertebral Fractures in Children and Young People With Osteogenesis Imperfecta N/A
Active, not recruiting NCT02814591 - Development of a Non-invasive Assessment of Human Bone Quality Using Spatially Offset Raman Spectroscopy
Completed NCT00982124 - An Efficacy and Safety Trial of Intravenous Zoledronic Acid in Infants Less Than One Year of Age, With Severe Osteogenesis Imperfecta Phase 3
Not yet recruiting NCT05612139 - Post-market Observational Study on JTIN Telescopic Nail in Osteogenesis Imperfecta Pediatric Patients
Completed NCT00001305 - Growth Hormone Therapy in Osteogenesis Imperfecta Phase 3
Completed NCT04119388 - Evaluation of the Benefits of Adaptive Physical Activity in Children and Adolescents With Osteogenesis Imperfecta N/A
Terminated NCT01679080 - The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta Phase 2
Recruiting NCT04152551 - Effects of Bisphosphonates on OI-Related Hearing Loss Phase 4
Completed NCT00705120 - Treatment of Severe Osteogenesis Imperfecta by Allogeneic Bone Marrow Transplantation Phase 1
Suspended NCT04169568 - Osteogenesis Imperfecta Blood Pressure Study
Completed NCT03064074 - Safety of Fresolimumab in the Treatment of Osteogenesis Imperfecta Phase 1
Not yet recruiting NCT05258019 - Site Preservation After Tooth Extraction