NCT00844129

Brief Summary

The purpose of this study is to determine the incidence and clinical history of neurofibromatosis type 1-related spinal abnormalities.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 3, 2018

Status Verified

April 1, 2018

Enrollment Period

6 years

First QC Date

February 12, 2009

Last Update Submit

April 30, 2018

Conditions

Neurofibromatosis Type 1

Keywords

neurofibromatosis type 1spinal abnormalitiesscoliosis

Outcome Measures

Primary Outcomes (1)

  • Scoliosis and it's progression

    4 years

Secondary Outcomes (1)

  • 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).

    4 years

Study Arms (1)

Neurofibromatosis Type 1

Children with Neurofibromatosis Type 1

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The cohort will be recruited from a primary care clinic.

You may qualify if:

  • Diagnosis of NF1
  • Age greater than 6 years at time of enrollment
  • Age less than 9 year and 1 day at time of enrollment
  • Tanner Stage not greater than 1

You may not qualify if:

  • Prior surgical repair of spine
  • Short-segment (4-6 vertebrae) curve with a Cobb angle of 45°or more
  • Hormone replacement therapy
  • Chronic steroid use
  • Tibial pseudarthrosis
  • Other chronic medical problems known to influence bone health (i.e. diabetes mellitus, cerebral palsy, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Care, 50 North Medical Drive

Salt Lake City, Utah, 84132, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine

MeSH Terms

Conditions

Neurofibromatosis 1Scoliosis

Condition Hierarchy (Ancestors)

NeurofibromatosesNeurofibromaNerve Sheath NeoplasmsNeoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasmsNeoplastic Syndromes, HereditaryNeurocutaneous SyndromesNervous System DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSpinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • David Viskochil, MD, PhD

    Division of Medical Genetics, Department of Pediatrics, University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 12, 2009

First Posted

February 13, 2009

Study Start

December 1, 2006

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

May 3, 2018

Record last verified: 2018-04

Locations

US(1)