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

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

Purpose

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.

Condition	Intervention	Phase
Osteogenesis Imperfecta	Drug: Zoledronic Acid	Phase II

Genetics Home Reference related topics: Melnick-Needles syndrome osteogenesis imperfecta

MedlinePlus related topics: Osteogenesis Imperfecta

Drug Information available for: Zoledronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta

Further study details as provided by Novartis:

Primary Outcome Measures:

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 Measures:

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

Estimated Enrollment:	127
Study Start Date:	July 2004

Eligibility

Ages Eligible for Study:	1 Year to 17 Years
Genders Eligible for Study:	Both

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131118

Locations

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

Sponsors and Collaborators

Novartis

More Information

Novartis patient recruitment website This link exits the ClinicalTrials.gov site

Study ID Numbers:	CZOL446H2202E1
Study First Received:	August 15, 2005
Last Updated:	September 25, 2007
ClinicalTrials.gov Identifier:	NCT00131118
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Osteogenesis Imperfecta, Brittle bone disease, bisphosphonate, children

Study placed in the following topic categories:

Osteogenesis Imperfecta
Diphosphonates
Zoledronic acid
Osteogenesis imperfecta
Collagen Diseases
Genetic Diseases, Inborn

Musculoskeletal Diseases
Connective Tissue Diseases
Bone Diseases, Developmental
Osteochondrodysplasias
Bone Diseases

Additional relevant MeSH terms:

Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009