Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Longitudinal Assessment of Bone Growth in Children With Cerebral Palsy

This study has been completed.
Sponsor:
Collaborators:
Kent State University
University of North Carolina
Alfred I. duPont Hospital for Children
Information provided by:
Akron Children's Hospital
ClinicalTrials.gov Identifier:
NCT01019122
First received: November 20, 2009
Last updated: March 8, 2011
Last verified: March 2011

November 20, 2009
March 8, 2011
October 2009
July 2010   (final data collection date for primary outcome measure)
Dual Energy X-ray Absorptiometry (DEXA) scan results [ Time Frame: 6 years from original DEXA scan ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01019122 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Longitudinal Assessment of Bone Growth in Children With Cerebral Palsy
Longitudinal Assessment of Bone Growth and Development in a Facility-Based Population of Children With Cerebral Palsy

In 2003, observational growth and bone density data was obtained on children with cerebral palsy (CP) living at Hattie Larlham as part of a study comparing growth with an existing database of children with CP who live at home. The original residents included in that study are now of adult age. Due to the lack of longitudinal bone density measurements in facility-based adults with severe CP, the investigators' objective is to obtain 6-year follow-up data from the residents enrolled in the original study.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Residents of a long-term care facility for children with disabilities who have severe to profound CP and are non-ambulatory.

  • Cerebral Palsy
  • Bone Density
Radiation: Dexa Scan
Dexa scan of left and right distal femur, then lumbar spine, and whole body when possible
Dexa Scan
Eligible patients from 2003 study will receive a follow-up Dexa scan.
Intervention: Radiation: Dexa Scan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
November 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Resident of Hattie Larlham Center for Children with Disabilities (HLCCD)
  • Previously enrolled in the Growth in a Facility-Based Population of Children with Cerebral Palsy study in 2003

Exclusion Criteria:

  • Resident of HLCCD who was not enrolled in the Growth in a Facility-Based Population of Children with Cerebral Palsy study
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01019122
Bone Growth in CP Patients
No
Richard Grossberg, MD, Hattie Larlham Center for Children with Disabilities
Akron Children's Hospital
  • Kent State University
  • University of North Carolina
  • Alfred I. duPont Hospital for Children
Study Chair: Martha Blackford, PharmD Akron Children's Hospital
Study Chair: Michael Reed, PharmD Akron Children's Hospital
Study Chair: Richard Henderson, MD, PhD University of North Carolina
Akron Children's Hospital
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP