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NCT00063479 Clinical Trial

Bisphosphonate Treatment of Osteogenesis Imperfecta

Osteogenesis Imperfecta Clinical Trial

Official title:
Bisphosphonate Treatment of Osteogenesis Imperfecta

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00063479
Other study ID # CZOL446H2202
Secondary ID
Status Completed
Phase Phase 2
First received June 27, 2003
Last updated May 31, 2017
Start date June 2003
Est. completion date May 2007

Study information
Verified date May 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary purpose of this trial is to evaluate whether the investigational medication is safe, effective and has the ability to increase spine bone density in osteogenesis imperfecta (OI) patients.

Recruitment information / eligibility
Status Completed
Enrollment 158
Est. completion date May 2007
Est. primary completion date May 2007
Accepts healthy volunteers No
Gender All
Age group 3 Months to 17 Years
Eligibility Inclusion

- Male or Female children between 3 months and 17 years old

- OI type I, III or IV

Exclusion

- Deformity or abnormality which would prevent spine bone density from being done

- Any surgical bone-lengthening procedure

- Any kidney diseases or abnormalities

- Low calcium or vitamin D levels in the blood

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Zoledronic Acid

Locations
Country Name City State
United States Intermountain Orthopedics Boise Idaho
United States Children's Hospital Medical Center Cincinnati Ohio
United States Children's Hospital Columbus Ohio
United States Texas Children's Hosptial Houston Texas
United States UCLA - Division of Pediatric Nephrology Los Angeles California
United States Vanderbilt University Medical Center Nashville Tennessee
United States Children's Hospital Omaha Nebraska
United States St. Jude Children's Research Hospital Peoria Illinois
United States Oregon Health Sciences University Portland Oregon
United States Alfred I. DuPont Hospital for Children Wilmington Delaware

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in lumbar spine bone mineral density at month 12 relative to baseline
Secondary Change in Z score of the lumbar spine at month 12 relative to baseline
See also
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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
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
Completed NCT00106028 - Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children Phase 3
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
Recruiting NCT04169568 - Osteogenesis Imperfecta Blood Pressure Study
Completed NCT03064074 - Safety of Fresolimumab in the Treatment of Osteogenesis Imperfecta Phase 1

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