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Bisphosphonate Treatment of Osteogenesis Imperfecta

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ClinicalTrials.gov Identifier: NCT00063479
Recruitment Status : Completed
First Posted : June 30, 2003
Last Update Posted : June 1, 2017
Sponsor:
Information provided by:
Novartis

June 27, 2003
June 30, 2003
June 1, 2017
June 2003
May 2007   (Final data collection date for primary outcome measure)
Change in lumbar spine bone mineral density at month 12 relative to baseline
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Complete list of historical versions of study NCT00063479 on ClinicalTrials.gov Archive Site
Change in Z score of the lumbar spine at month 12 relative to baseline
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Bisphosphonate Treatment of Osteogenesis Imperfecta
Bisphosphonate Treatment of Osteogenesis Imperfecta
The primary purpose of this trial is to evaluate whether the investigational medication is safe, effective and has the ability to increase spine bone density in osteogenesis imperfecta (OI) patients.
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Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Osteogenesis Imperfecta
Drug: Zoledronic Acid
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
158
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May 2007
May 2007   (Final data collection date for primary outcome measure)

Inclusion

  • Male or Female children between 3 months and 17 years old
  • OI type I, III or IV

Exclusion

  • 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.

Sexes Eligible for Study: All
3 Months to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
Germany
 
NCT00063479
CZOL446H2202
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Novartis Pharmaceuticals
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Novartis
May 2017

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