Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT00063479 |
Date of registration:
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27/06/2003 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Bisphosphonate Treatment of Osteogenesis Imperfecta
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Scientific title:
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Bisphosphonate Treatment of Osteogenesis Imperfecta |
Date of first enrolment:
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June 2003 |
Target sample size:
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158 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT00063479 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Germany
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United States
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Key inclusion & exclusion criteria
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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.
Age minimum:
3 Months
Age maximum:
17 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Osteogenesis Imperfecta
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Intervention(s)
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Drug: Zoledronic Acid
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Primary Outcome(s)
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Change in lumbar spine bone mineral density at month 12 relative to baseline
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Secondary Outcome(s)
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Change in Z score of the lumbar spine at month 12 relative to baseline
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Secondary ID(s)
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CZOL446H2202
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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