Survivors of Bone Marrow TransplantNCT00558948
Musculoskeletal Outcomes After Bone Marrow Transplant
An observational study of Survivors of Bone Marrow Transplant and Autologous and Allogeneic, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 30 years
- Conditions the study is for
- Survivors of Bone Marrow Transplant, Autologous and Allogeneic
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Aug 2009
- 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 8 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Survivors of bone marrow transplant (autologous and allogeneic) who are at least 1 year from transplant.
Who may be able to join
- Ages 8-30 years
- One year from transplant
Who cannot join
- No current steroid use
- Medical conditions that would prohibit testing
- Neuropsychological conditions that prohibit completing questionnaires
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University, Bayview Campus
Baltimore, Maryland, 21212
About this study
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.
Read the 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.
- Keywords
- Bone Marrow Transplant, Bone Mineral Density, Survivors, Muscle Strength
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study startMay 2007
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Survivors of Bone Marrow TransplantStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Kathy Ruble, PhDc, RN, Study director, Johns Hopkins University, School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00558948
- Sponsor's protocol ID
- J06120
- Other IDs
- 1F31NR010038-01
- Status last verified
- Aug 2009
- First submitted
- 14 Nov 2007
- Last updated
- 19 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musculoskeletal Outcomes After Bone Marrow Transplant
- ClinicalTrials.gov ID
- NCT00558948
- Acronym / sponsor ID
- J06120
- Keywords
- Bone Marrow Transplant, Bone Mineral Density, Survivors, Muscle Strength
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 16 Nov 2007 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 8 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Survivors of bone marrow transplant (autologous and allogeneic) who are at least 1 year from transplant.
Key inclusion criteria (2 listed)
- Ages 8-30 years
- One year from transplant
Key exclusion criteria (3 listed)
- No current steroid use
- Medical conditions that would prohibit testing
- Neuropsychological conditions that prohibit completing questionnaires
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2009.
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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.
Kathy Ruble, PhDc, RN study director
Johns Hopkins University, School of Nursing
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 Survivors of Bone Marrow Transplant and Autologous and Allogeneic, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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?
The sponsor lists 2 inclusion and 3 exclusion criteria. 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: finished, as of the sponsor's last update on 19 Aug 2009. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 19 Aug 2009.