Back to resultsZoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta
Primary Purpose
Osteogenesis Imperfecta
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Zoledronic Acid
Sponsored by
About this trial
This is an interventional treatment trial for Osteogenesis Imperfecta focused on measuring Osteogenesis Imperfecta, Brittle bone disease, bisphosphonate, children
Eligibility Criteria
Inclusion Criteria: Have completed the core CZOL446H2202 study Males or females between 1-17 years of age Exclusion Criteria: 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.
Sites / Locations
- UCLA Medical Center-Dept of Pediatric Nephrology
- Alfred Dupont Hospital for Children
- Intermountains Orthopedics
- Children's Hospital
- For information regarding facilities, please contact the Central Contact
- Children's Hospital Medical Center
- Children's Hospital
- Oregon Health Sciences University
- Vanderbilt University Medical Center
- Texas Children's Hospital
Outcomes
Primary Outcome Measures
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 Outcome Measures
Measure percentage change of lumbar spine bone mineral density at month 18 and 24 compared to baseline in the core study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00131118
Brief Title
Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta
Official Title
Efficacy and Safety of Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteogenesis Imperfecta
Keywords
Osteogenesis Imperfecta, Brittle bone disease, bisphosphonate, children
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
127 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Zoledronic Acid
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Measure percentage change of lumbar spine bone mineral density at month 18 and 24 compared to baseline in the core study.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Eligibility Criteria
Inclusion Criteria:
Have completed the core CZOL446H2202 study
Males or females between 1-17 years of age
Exclusion Criteria:
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.
Facility Information:
Facility Name
UCLA Medical Center-Dept of Pediatric Nephrology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Alfred Dupont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19899
Country
United States
Facility Name
Intermountains Orthopedics
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Children's Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
For information regarding facilities, please contact the Central Contact
City
Multiple Locations
State/Province
New Jersey
Country
United States
Facility Name
Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.novartisclinicaltrials.com/etrials/searchTrial.do?trialID=371
Description
Novartis patient recruitment website
Learn more about this trial
Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta
We'll reach out to this number within 24 hrs