Bisphosphonate Treatment of Osteogenesis Imperfecta - Full Text View

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

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, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Bisphosphonate Treatment of Osteogenesis Imperfecta

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

Study ID Numbers:	CZOL446H2202
First Received:	June 27, 2003
Last Updated:	September 25, 2007
ClinicalTrials.gov Identifier:	NCT00063479
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

Study placed in the following topic categories:

Osteogenesis Imperfecta

Osteogenesis imperfecta

Zoledronic acid

Collagen Diseases

Fractures, Bone

Osteochondrodysplasias

Bone Diseases

Diphosphonates

Musculoskeletal Diseases

Genetic Diseases, Inborn

Bone Diseases, Developmental

Connective Tissue Diseases

Pamidronate

Additional relevant MeSH terms:

Physiological Effects of Drugs

Bone Density Conservation Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008

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