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Bisphosphonate Treatment of Osteogenesis Imperfecta

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00063479
First Posted: June 30, 2003
Last Update Posted: June 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bisphosphonate Treatment of Osteogenesis Imperfecta

Resource links provided by NLM:


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
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   3 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Pharmaceuticals
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00063479     History of Changes
Other Study ID Numbers: CZOL446H2202
First Submitted: June 27, 2003
First Posted: June 30, 2003
Last Update Posted: June 1, 2017
Last Verified: May 2017

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