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NCT00131118 Clinical Trial

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

Osteogenesis Imperfecta Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00131118
Other study ID # CZOL446H2202E1
Secondary ID
Status Completed
Phase Phase 2
First received August 15, 2005
Last updated May 31, 2017
Start date July 2004
Est. completion date May 2007

Study information
Verified date November 2016
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 127
Est. completion date May 2007
Est. primary completion date May 2007
Accepts healthy volunteers
Gender All
Age group 1 Year to 17 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Zoledronic Acid

Locations
Country Name City State
United States Intermountains Orthopedics Boise Idaho
United States Children's Hospital Medical Center Cincinnati Ohio
United States Children's Hospital Columbus Ohio
United States Texas Children's Hospital Houston Texas
United States UCLA Medical Center-Dept of Pediatric Nephrology Los Angeles California
United States For information regarding facilities, please contact the Central Contact Multiple Locations New Jersey
United States Vanderbilt University Medical Center Nashville Tennessee
United States Children's Hospital Omaha Nebraska
United States Oregon Health Sciences University Portland Oregon
United States Alfred Dupont Hospital for Children Wilmington Delaware

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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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