Multi-Center Project: Spinal Abnormalities in Neurofibromatosis Type1 (NF1) Patients
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|ClinicalTrials.gov Identifier: NCT00667836|
Recruitment Status : Unknown
Verified April 2008 by Shriners Hospitals for Children.
Recruitment status was: Recruiting
First Posted : April 28, 2008
Last Update Posted : April 28, 2008
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.
|Condition or disease|
|Neurofibromatosis Type 1|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Multi-Center Project: Spinal Abnormalities in Neurofibromatosis Type1 (NF1) Patients|
|Study Start Date :||March 2006|
|Estimated Primary Completion Date :||September 2009|
|Estimated Study Completion Date :||September 2009|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00667836
|Contact: Susan J Geyer, CCRPfirstname.lastname@example.org|
|Contact: Jeanne Siebert, RN, CCRpemail@example.com|
|United States, Utah|
|Shriners Hospitals for Children, Salt Lake City||Recruiting|
|Salt Lake City, Utah, United States, 84103|
|Contact: Susan J Geyer, CCRP 801-536-3561 firstname.lastname@example.org|
|Contact: Jeanne Siebert, RN, CCRP 801-536-3601 jsiebert @shrinenet.org|
|Principal Investigator: Jacques D'Astous, M.D.|
|Principal Investigator:||Jacques D'Astous, M.D.||Shriners Hospitals for Children|