Musculoskeletal Outcomes After Bone Marrow Transplant | NCT00558948

Studies
Musculoskeletal Outcomes After Bone Marrow Transplant

NCT00558948

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Status

Completed

Last Update Posted

Aug 19, 2009Estimated

Enrollment

48Actual

Phase

Not provided

Conditions

Survivors of Bone Marrow Transplant
Autologous and Allogeneic

Interventions

Not provided

Countries

United States

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

ID	Type	Description	Link
1F31NR010038-01	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Aug 2009

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

May 2007

Primary Completion Date

Aug 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Nov 14, 2007

First Submission Date that Met QC Criteria

Nov 15, 2007

First Posted Date

Nov 16, 2007Estimated

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

Aug 18, 2009

Last Update Posted Date

Aug 19, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of the study is to evaluate bone mineral density and muscle strength in survivors of bone marrow transplant. Association with age, type of transplant, steroids, years since transplant, body composition, endocrinopathies, radiation, quality of life and physical activity will be explored.

Detailed Description

Bone marrow transplant survivors are at risk of diminished bone mineral density. Mechanisms and risks are not well understood. This study will help identify risks factors for developing this complication.

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

48Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ages 8-30 years
One year from transplant

Exclusion Criteria:

No current steroid use
Medical conditions that would prohibit testing
Neuropsychological conditions that prohibit completing questionnaires

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

30 Years

Standard Ages

ChildAdult

Study Population

Survivors of bone marrow transplant (autologous and allogeneic) who are at least 1 year from transplant.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kathy Ruble, PhDc, RN	Johns Hopkins University, School of Nursing	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Johns Hopkins University, Bayview Campus		Baltimore	Maryland	21212	United States