An observational study in Neurofibromatosis Type 1, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 6 Years to 9 Years. Per ClinicalTrials.gov, last updated 2018-05-03.
Sponsored by University of Utah · Observational
The purpose of this study is to determine the incidence and clinical history of neurofibromatosis type 1-related spinal abnormalities.
Neurofibromatosis type 1 (NF1) is a common genetic disorder that is associated with spinal abnormalities which are varied and may include scoliosis, neurofibromas, meningoceles, and vertebral defects. Skeletal abnormalities occur in more than one third of individuals with the disorder. These abnormalities are unpredictable and the pathogenesis, natural history, and clinical outcome remain relatively unclear.
The primary objective of this study is to determine the incidence and clinical history of NF1-related spinal abnormalities in children with NF1, over a 3-year period.
In the study, researchers will enroll children between ages 6 and 9 years who have been diagnosed with NF1 to look at changes in the spine. Participants in the study will be followed yearly for a total of 4 evaluations. Evaluations may include bone scans, spinal x-rays, magnetic resonance imaging (MRI), computed tomography (CT) scans, and urine samples.
Information gained from this study may lead to a better understanding of the causes of bone disease in NF1, and improved treatment.
186 studies on the registry are indexed under Neurofibromatoses; 24 are open to participants now.
This study's enrollment of 112 is above the median of 78 across 56 observational studies indexed under Neurofibromatoses.
Browse Neurofibromatoses studies →University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.
Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
The cohort will be recruited from a primary care clinic.
Exclusion Criteria:
Children with Neurofibromatosis Type 1
Scoliosis and it's progression
Time frame: 4 years
Differences in other bone health variables as measured by thoracic MRIs, Dexa (xray measuring bone density), pQCT (a cross sectional picture of the tibia), urine analysis, and scoli series (xrays to look for scoliosis).
Time frame: 4 years
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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University of Utah