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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

August 15, 2005
April 26, 2012
July 2004
May 2007   (final data collection date for primary outcome measure)
Long-term safety of two different zoledronic acid doses over an additional 12 months in patients who have completed one year treatment in CZOL446H2202
Not Provided
Complete list of historical versions of study NCT00131118 on ClinicalTrials.gov Archive Site
Measure percentage change of lumbar spine bone mineral density at month 18 and 24 compared to baseline in the core study.
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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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteogenesis Imperfecta
Drug: Zoledronic Acid
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
127
May 2007
May 2007   (final data collection date for primary outcome measure)

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.

Both
1 Year to 17 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00131118
CZOL446H2202E1
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Not Provided
Novartis
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP