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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy and Safety of Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta

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.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Long-term safety of two different zoledronic acid doses over an additional 12 months in patients who have completed one year treatment in CZOL446H2202

Original Primary Outcome:

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

Original Secondary Outcome:

Information By: Novartis

Dates:
Date Received: August 15, 2005
Date Started: July 2004
Date Completion:
Last Updated: April 20, 2017
Last Verified: November 2016