Trial record 3 of 20 for:
"Osteogenesis imperfecta"
Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00131118
First received: August 15, 2005
Last updated: April 26, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteogenesis Imperfecta |
Drug: Zoledronic Acid |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Efficacy and Safety of Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta |
Resource links provided by NLM:
MedlinePlus related topics:
Osteogenesis Imperfecta
Drug Information available for:
Zoledronic acid
U.S. FDA Resources
Further study details as provided by Novartis:
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.
| Estimated Enrollment: | 127 |
| Study Start Date: | July 2004 |
| Study Completion Date: | May 2007 |
| Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 1 Year to 17 Years |
| Genders Eligible for Study: | Both |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00131118
Locations
| United States, California | |
| UCLA Medical Center-Dept of Pediatric Nephrology | |
| Los Angeles, California, United States, 90095 | |
| United States, Delaware | |
| Alfred Dupont Hospital for Children | |
| Wilmington, Delaware, United States, 19899 | |
| United States, Idaho | |
| Intermountains Orthopedics | |
| Boise, Idaho, United States, 83702 | |
| United States, Nebraska | |
| Children's Hospital | |
| Omaha, Nebraska, United States, 68198 | |
| United States, New Jersey | |
| For information regarding facilities, please contact the Central Contact | |
| Multiple, New Jersey, United States | |
| United States, Ohio | |
| Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229 | |
| Children's Hospital | |
| Columbus, Ohio, United States, 43205 | |
| United States, Oregon | |
| Oregon Health Sciences University | |
| Portland, Oregon, United States, 97239 | |
| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| Texas Children's Hospital | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
More Information
Additional Information:
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00131118 History of Changes |
| Other Study ID Numbers: | CZOL446H2202E1 |
| Study First Received: | August 15, 2005 |
| Last Updated: | April 26, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Novartis:
|
Osteogenesis Imperfecta, Brittle bone disease, bisphosphonate, children |
Additional relevant MeSH terms:
|
Osteogenesis Imperfecta Osteochondrodysplasias Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Genetic Diseases, Inborn Collagen Diseases |
Connective Tissue Diseases Zoledronic acid Diphosphonates Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013