Bisphosphonate Treatment of Osteogenesis Imperfecta
1 other identifier
interventional
158
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2003
Typical duration for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
June 27, 2003
CompletedFirst Posted
Study publicly available on registry
June 30, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedJune 1, 2017
May 1, 2017
3.9 years
June 27, 2003
May 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in lumbar spine bone mineral density at month 12 relative to baseline
Secondary Outcomes (1)
Change in Z score of the lumbar spine at month 12 relative to baseline
Interventions
Eligibility Criteria
You may qualify if:
- Male or Female children between 3 months and 17 years old
- OI type I, III or IV
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
UCLA - Division of Pediatric Nephrology
Los Angeles, California, 90024, United States
Alfred I. DuPont Hospital for Children
Wilmington, Delaware, 19899, United States
Intermountain Orthopedics
Boise, Idaho, 83702, United States
St. Jude Children's Research Hospital
Peoria, Illinois, 61637, United States
Children's Hospital
Omaha, Nebraska, 68198, United States
Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Children's Hospital
Columbus, Ohio, 43205, United States
Oregon Health Sciences University
Portland, Oregon, 97201, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Texas Children's Hosptial
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 27, 2003
First Posted
June 30, 2003
Study Start
June 1, 2003
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
June 1, 2017
Record last verified: 2017-05