Bisphosphonate Treatment of Osteogenesis Imperfecta

This study has been completed.

First Received on June 27, 2003. Last Updated on September 25, 2007 History of Changes

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00063479

Purpose

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.

Condition	Intervention	Phase
Osteogenesis Imperfecta	Drug: Zoledronic Acid	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Bisphosphonate Treatment of Osteogenesis Imperfecta

Resource links provided by NLM:

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

MedlinePlus related topics: Bone Density Bone Diseases Osteogenesis Imperfecta

Drug Information available for: Zoledronic acid

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Change in lumbar spine bone mineral density at month 12 relative to baseline

Secondary Outcome Measures:

Change in Z score of the lumbar spine at month 12 relative to baseline

Estimated Enrollment:	158
Study Start Date:	June 2003

Eligibility

Ages Eligible for Study:	3 Months to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00063479

Locations

United States, California
UCLA - Division of Pediatric Nephrology
Los Angeles, California, United States, 90024
United States, Delaware
Alfred I. DuPont Hospital for Children
Wilmington, Delaware, United States, 19899
United States, Idaho
Intermountain Orthopedics
Boise, Idaho, United States, 83702
United States, Illinois
St. Jude Children's Research Hospital
Peoria, Illinois, United States, 61637
United States, Nebraska
Children's Hospital
Omaha, Nebraska, United States, 68198
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, 97201
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Children's Hosptial
Houston, Texas, United States, 77030

Sponsors and Collaborators

Novartis

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00063479 History of Changes
Other Study ID Numbers:	CZOL446H2202
Study First Received:	June 27, 2003
Last Updated:	September 25, 2007
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Osteogenesis Imperfecta
OI
bone markers
fracture
bone loss

pediatric
bisphosphonate
brittle bone disease
pamidronate

Additional relevant MeSH terms:

Osteogenesis Imperfecta
Osteochondrodysplasias
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Collagen Diseases

Connective Tissue Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012