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Efficacy and Safety of Zoledronic Acid in Children (1 -17 Years) with Severe Osteogenesis Imperfecta - Article


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General Topics A-Z

Osteogenesis Imperfecta

Brittle bone disease; Ekman-Lobstein disease; Fragilitas ossium; OI; Osteopsathyrosis; Vrolik disease

Clinical Trial: Efficacy and Safety of Zoledronic Acid in Children (1 -17 Years) with Severe Osteogenesis Imperfecta

This study is currently recruiting patients.
Verified by Novartis August 2005

Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00131118

Purpose

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 II

MedlinePlus related topics:  Osteogenesis Imperfecta
Genetics Home Reference related topics:  osteogenesis imperfecta

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Further Study Details: 

Study start: July 2005

Eligibility

Ages Eligible for Study:  1 Year   -   17 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Have completed the core CZOL446H2202 study
  • Male or female between 1-17 years

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00131118

Novartis Pharmaceuticals      862-778-8300 

New Jersey
      For information regarding facilities, please contact the Central Contact, Multiple,  New Jersey,  United States; Recruiting
Novartis Pharmaceuticals  862-778-8300 

More Information

Study ID Numbers:  CZOL446H2202E1
Last Updated:  August 16, 2005
Record first received:  August 15, 2005
ClinicalTrials.gov Identifier:  NCT00131118
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23


Source: ClinicalTrials.gov
Cache Date: August 24, 2005


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Page Updated: October 3, 2005
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