Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta

This study has been completed.
Sponsor:
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Bone Diseases
Bone Diseases, Developmental
Collagen Diseases
Connective Tissue Diseases
Genetic Diseases, Inborn
Musculoskeletal Diseases
Osteochondrodysplasias
Diphosphonates
Zoledronic acid
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014