Bisphosphonate Treatment of Osteogenesis Imperfecta

Phase 2

Completed

• Conditions: Osteogenesis Imperfecta

• Registration Number: NCT00063479
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2003-06-27
• Study First Submitted QC: 2003-06-27
• Study First Posted: 2003-06-30
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-31
• Last Update Posted: 2017-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (9)

Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

UCLA - Division of Pediatric Nephrology; 🇺🇸 Los Angeles, California, United States

Texas Children's Hosptial; 🇺🇸 Houston, Texas, United States

Intermountain Orthopedics; 🇺🇸 Boise, Idaho, United States

Children's Hospital; 🇺🇸 Columbus, Ohio, United States

St. Jude Children's Research Hospital; 🇺🇸 Peoria, Illinois, United States

Oregon Health Sciences University; 🇺🇸 Portland, Oregon, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Alfred I. DuPont Hospital for Children; 🇺🇸 Wilmington, Delaware, United States