NCT00594295

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2007

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

June 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 15, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

October 5, 2015

Status Verified

April 1, 2010

Enrollment Period

1.1 years

First QC Date

January 3, 2008

Last Update Submit

October 1, 2015

Conditions

Osteoporotic Fractures

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Bone marrow transplant patients at least 6 years post transplant

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin Hospitals and Clinics

Madison, Wisconsin, 53705, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood, serum

MeSH Terms

Conditions

Osteoporotic Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Study Officials

  • Neil C Binkley, MD

    University of Wisconsin - Institute on Aging

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2008

First Posted

January 15, 2008

Study Start

June 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

October 5, 2015

Record last verified: 2010-04

Locations

US(1)