OsteoporosisNCT00008788
Osteoporosis in Children and Adults Following Liver Transplantation
An observational study of Osteoporosis and Liver Transplantation, run by National Center for Research Resources (NCRR) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Osteoporosis, Liver Transplantation
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
- Liver transplantation in childhood or young adulthood
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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.
Read the detailed 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.
- Conditions
- Osteoporosis, Liver Transplantation
- Medical subject headings
- Osteoporosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00008788
- Sponsor's protocol ID
- NCRR-M01RR00400-0664
- Status last verified
- Dec 2003
- First submitted
- 16 Jan 2001
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteoporosis in Children and Adults Following Liver Transplantation
- ClinicalTrials.gov ID
- NCT00008788
- Acronym / sponsor ID
- NCRR-M01RR00400-0664
- Conditions
- Osteoporosis, Liver Transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- First posted
- 18 Jan 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Defined population
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Liver Transplantation, run by National Center for Research Resources (NCRR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.