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

Sponsors

Lead Sponsor: Novartis Pharmaceuticals

Source Novartis
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.

Overall Status Completed
Start Date July 2004
Completion Date May 2007
Primary Completion Date May 2007
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Measure Time Frame
Measure percentage change of lumbar spine bone mineral density at month 18 and 24 compared to baseline in the core study.
Enrollment 127
Condition
Intervention

Intervention Type: Drug

Intervention Name: Zoledronic Acid

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 1 Year

Maximum Age: 17 Years

Location
Facility:
UCLA Medical Center-Dept of Pediatric Nephrology | Los Angeles, California, 90095, United States
Alfred Dupont Hospital for Children | Wilmington, Delaware, 19899, United States
Intermountains Orthopedics | Boise, Idaho, 83702, United States
Children's Hospital | Omaha, Nebraska, 68198, United States
For information regarding facilities, please contact the Central Contact | Multiple Locations, New Jersey, United States
Children's Hospital Medical Center | Cincinnati, Ohio, 45229, United States
Children's Hospital | Columbus, Ohio, 43205, United States
Oregon Health Sciences University | Portland, Oregon, 97239, United States
Vanderbilt University Medical Center | Nashville, Tennessee, 37232, United States
Texas Children's Hospital | Houston, Texas, 77030, United States
Location Countries

United States

Verification Date

November 2016

Responsible Party

Type: Sponsor

Keywords
Condition Browse
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov