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NCT00008788 Clinical Trial

Osteoporosis in Children and Adults Following Liver Transplantation

Osteoporosis Clinical Trial

Official title:
Osteoporosis in Children and Adults Following Liver Transplantation

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00008788
Other study ID # NCRR-M01RR00400-0664
Secondary ID
Status Active, not recruiting
Phase N/A
First received January 16, 2001
Last updated June 23, 2005

Study information
Verified date December 2003
Source National Center for Research Resources (NCRR)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

This pilot project aims to 1) estimate the prevalence of osteoporosis in adults having undergone liver transplantation in childhood, and 2) identify risk factors for osteoporosis in this group. We aim to study 40 individuals.

Description:

Background: Osteoporosis is defined as an absolute decrease in the amount of bone (volume and/or density). Chronic liver disease is associated with osteoporosis in both adults and children. Bone density is also decreased in the months immediately after liver transplantation, but improves to pretransplant values after 1 to 2 years. Immunosuppressive agents, most notably steroids, are a cause of osteoporosis. However, studies on adults have shown that bone densities afer transplantation continue to improve within the normal range for healthy adults. In the case of children, bone accretion is necessary for growth. Chronic liver disease and transplantation in childhood will have an adverse effect on bone metabolism and the outcome in terms of bone density after the growth period cannot be predicted on individuals transplanted as adults or other transplant groups.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 40
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 40 Years
Eligibility - Liver transplantation in childhood or young adulthood

Study Design

Observational Model: Defined Population, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

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