Follow-up of Bone Quality in Long-Term Bone Marrow Transp... | NCT00594295

Studies
Follow-up of Bone Quality in Long-Term Bone Marrow Transplant Survivors

NCT00594295

Sponsor

University of Wisconsin, Madison

Status

Completed

Last Update Posted

Oct 5, 2015Estimated

Enrollment

15Estimated

Phase

Not provided

Conditions

Osteoporotic Fractures

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

Status Module

Record Verification Date

Apr 2010

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

Jun 2007

Primary Completion Date

Jul 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

Jan 3, 2008

First Submission Date that Met QC Criteria

Jan 3, 2008

First Posted Date

Jan 15, 2008Estimated

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

Oct 1, 2015

Last Update Posted Date

Oct 5, 2015Estimated

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

Brittle and broken bones can occur after organ transplantation. However, the long-term effects of bone marrow transplantation on bone health and the risk of breaking bones are not well understood. This study will help to assess how common it is for those who have received a bone marrow transplant to have fractures. It will also investigate blood tests related to bone health. This will be done by measuring bone mineral density and obtaining blood tests.

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

Retention

Enrollment

15Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participation in the initial "Assessment of skeletal status following allogeneic bone marrow transplantation" Study (HSC97-632-408).
Able and willing to sign informed consent.

Exclusion Criteria:

All of the contacted long-term BMT survivors that are willing to participate will be included in this 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

Bone marrow transplant patients at least 6 years post transplant

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Neil C Binkley, MD	University of Wisconsin - Institute on Aging	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Wisconsin Hospitals and Clinics		Madison	Wisconsin	53705	United States

Condition Browse Module

MeSH Terms

ID	Term
D058866	Osteoporotic Fractures

Ancestor Terms

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries

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