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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01713231 |
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Date of registration:
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21/10/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of High-Dose Vitamin D on Bone Density in Osteogenesis Imperfecta
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Scientific title:
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Effect of High-Dose Vitamin D on Bone Density in Osteogenesis Imperfecta |
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Date of first enrolment:
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September 2012 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01713231 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
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Phase:
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Phase 4
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Countries of recruitment
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Canada
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Clinical diagnosis of OI of any type.
Exclusion Criteria:
- Any condition that renders bone density measurements at the lumbar spine impossible.
An example for this is prior spinal fusion surgery.
- Bisphosphonate therapy for less than two years duration.
- Use of medication, other than bisphosphonates, known to affect bone metabolism or
25OHD serum concentrations. Examples are anti-epileptics, active vitamin D
metabolites, corticosteroids and thyroid hormones.
- Liver and renal disease known to interfere with vitamin D metabolism.
- Any other disorder of calcium and phosphate metabolism (apart from vitamin D
deficiency) that might interfere with PTH.
Age minimum:
6 Years
Age maximum:
19 Years
Gender:
Both
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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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Dietary Supplement: high-dose vitamin D (2000 IU per day)
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Dietary Supplement: standard-dose vitamin D (400IU per day)
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Primary Outcome(s)
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Change in areal bone mineral density z-score of the lumbar spine
[Time Frame: at baseline and 12 months]
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Secondary Outcome(s)
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Change in trabecular and cortical volumetric bone mineral density z-scores at the radius, as measured by pQCT, relative to baseline.
[Time Frame: at baseline and at 12 months]
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Secondary ID(s)
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A02-M14-12A
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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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