Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta
Efficacy and Safety of Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta
1 other identifier
interventional
127
1 country
10
Brief Summary
This is an extension study to examine the long-term safety and efficacy of zoledronic acid in patients who have completed the core CZOL446H2202 study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2004
Typical duration for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 15, 2005
CompletedFirst Posted
Study publicly available on registry
August 17, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedJune 1, 2017
November 1, 2016
2.8 years
August 15, 2005
May 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Long-term safety of two different zoledronic acid doses over an additional 12 months in patients who have completed one year treatment in CZOL446H2202
Secondary Outcomes (1)
Measure percentage change of lumbar spine bone mineral density at month 18 and 24 compared to baseline in the core study.
Interventions
Eligibility Criteria
You may qualify if:
- Have completed the core CZOL446H2202 study
- Males or females between 1-17 years of age
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
UCLA Medical Center-Dept of Pediatric Nephrology
Los Angeles, California, 90095, United States
Alfred Dupont Hospital for Children
Wilmington, Delaware, 19899, United States
Intermountains Orthopedics
Boise, Idaho, 83702, United States
Children's Hospital
Omaha, Nebraska, 68198, United States
For information regarding facilities, please contact the Central Contact
Multiple Locations, New Jersey, United States
Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Children's Hospital
Columbus, Ohio, 43205, United States
Oregon Health Sciences University
Portland, Oregon, 97239, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2005
First Posted
August 17, 2005
Study Start
July 1, 2004
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
June 1, 2017
Record last verified: 2016-11