Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Salt Lake City, Utah 84103


Purpose:

We propose to establish a multi-center study to investigate the outcome of scoliosis and spinal abnormalities in patients with NF1. The three specific aims of this study are: Specific Aim 1 - To assess health status and health-related quality of life (HRQL) in children and adolescents with NF1 and scoliosis. We hypothesize that children and adolescents with NF1 and scoliosis will experience an additional burden of morbidity due to scoliosis and a downward trajectory of health status and HRQL over time. Specific Aim 2 - To assess the natural history and short-term response to therapy in a cohort of children with NF1 and scoliosis prospectively diagnosed during the course of the four-year study period. We hypothesize that some NF1 patients with idiopathic scoliosis will modulate to the dystrophic form. We also hypothesize that NF1 patients with earlier presentation are more likely to have or modulate to the dystrophic form. Specific Aim 3 - To assess biochemical markers of bone metabolism in NF1 individuals. We hypothesize that NF1 individuals will have statistically significant differences in biochemical markers of bone metabolism compared to controls. We also hypothesize that NF1 individuals with scoliosis will have differences in biochemical markers of bone metabolism compared to NF1 individuals without scoliosis.


Criteria:

Inclusion Criteria: - Meet NIH diagnostic criteria for NF1 - Radiographic documentation of scoliosis will be necessary for inclusion as a "scolosis case" - Age between 3 and 18 years Exclusion Criteria: - Do not have NF1


NCT ID:

NCT00667836


Primary Contact:

Principal Investigator
Jacques D'Astous, M.D.
Shriners Hospitals for Children

Susan J Geyer, CCRP
Phone: 801-536-3561
Email: sgeyer@shrinenet.org


Backup Contact:

Email: jsiebert@shrinenet.org
Jeanne Siebert, RN, CCRp
Phone: 801-536-3601


Location Contact:

Salt Lake City, Utah 84103
United States

Susan J Geyer, CCRP
Phone: 801-536-3561
Email: sgeyer@shrinenet.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.