Status:
COMPLETED
An Efficacy and Safety Trial of Intravenous Zoledronic Acid in Infants Less Than One Year of Age, With Severe Osteogenesis Imperfecta
Lead Sponsor:
Shriners Hospitals for Children
Collaborating Sponsors:
Novartis
Conditions:
Osteogenesis Imperfecta
Eligibility:
All Genders
Up to 12 years
Phase:
PHASE3
Brief Summary
The investigators have currently finished conducting an international multi-center trial that compares the efficacy and safety of pamidronate and zoledronate in the treatment of moderate to severe for...
Eligibility Criteria
Inclusion
- Children, male or female 2 weeks to \< 12 months of age, at least at 38 weeks gestational age.
- Any child with phenotypic OI type II, III or IV.
- Any child classified as OI type I, V-VIII that has had at least two or more previous fractures of long bone, or vertebral compression fractures, and a low bone mineral density.
- No previous treatment with bisphosphonates.
- Negative urine protein as measured by dipstick. One repeat assessment of the urine protein will be allowed.
Exclusion
- Blood oxygen saturation of less than 90% in room air.
- Serum creatinine level greater than 56 µmol/L.
- Any clinically significant clinical laboratory abnormalities at screening.
- Treatment with any investigational drug within the past 30 days.
- Patients who are unlikely to be able to complete the study or comply with the visit schedule.
- Any disease or planned therapy which will interfere with the procedures or data collection of this trial.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00982124
Start Date
October 1 2007
End Date
April 1 2016
Last Update
April 19 2016
Active Locations (1)
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1
Shriners Hospital for Children
Montreal, Quebec, Canada, H4A0A9