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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00131118
Recruitment Status : Completed
First Posted : August 17, 2005
Last Update Posted : June 1, 2017
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Osteogenesis Imperfecta Drug: Zoledronic Acid Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta
Study Start Date : July 2004
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Primary Outcome Measures :
  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 Outcome Measures :
  1. Measure percentage change of lumbar spine bone mineral density at month 18 and 24 compared to baseline in the core study.

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00131118

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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 Locations, 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
Additional Information:
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT00131118    
Other Study ID Numbers: CZOL446H2202E1
First Posted: August 17, 2005    Key Record Dates
Last Update Posted: June 1, 2017
Last Verified: November 2016
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Osteogenesis Imperfecta, Brittle bone disease, bisphosphonate, children
Additional relevant MeSH terms:
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Osteogenesis Imperfecta
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs