Longitudinal Assessment of Bone Growth in Children With C... | NCT01019122

Studies
Longitudinal Assessment of Bone Growth in Children With Cerebral Palsy

NCT01019122

Sponsor

Akron Children's Hospital

Status

Completed

Last Update Posted

Mar 10, 2011Estimated

Enrollment

56Estimated

Phase

Not provided

Conditions

Cerebral Palsy
Bone Density

Interventions

Dexa Scan

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Jul 2010Actual

Completion Date

Nov 2010Actual

First Submitted Date

Nov 20, 2009

First Submission Date that Met QC Criteria

Nov 23, 2009

First Posted Date

Nov 24, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2011

Last Update Posted Date

Mar 10, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Akron Children's HospitalOTHER

Collaborators

Name	Class
Kent State University	OTHER
University of North Carolina	OTHER
Alfred I. duPont Hospital for Children	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

56Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dexa Scan		Eligible patients from 2003 study will receive a follow-up Dexa scan.	Radiation: Dexa Scan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexa Scan	Radiation	Dexa scan of left and right distal femur, then lumbar spine, and whole body when possible	Dexa Scan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dual Energy X-ray Absorptiometry (DEXA) scan results		6 years from original DEXA scan

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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	Study Chair

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002547	Cerebral Palsy

Ancestor Terms

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015502	Absorptiometry, Photon

Ancestor Terms

ID	Term
D011859	Radiography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided