OsteoporosisNCT00615485
Longitudinal Study of Bone Mineral Density in Survivors of Solid Pediatric Cancers
An observational study of Osteoporosis, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
Specific subgroups of children who survive treatment for childhood malignancies have been shown to develop relative osteopenia following chemotherapy and are felt to be at risk for developing osteoporosis later in life due to their inability to reach peak bone mass during childhood. Read more about this study
- Who is it for?
- Ages 7 to 40 years
- Conditions the study is for
- Osteoporosis
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to May 2013
- 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 7 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The 38 patients from the SUNY Upstate Medical Center (Syracuse, NY) Pediatric Oncology Long-term Survivor Clinic who were subjects in the original Georg Fund supported study will comprise the patient population if they are locatable and willing to participate. Patients must be less than 40 years of age to participate.
Who may be able to join
- The 38 patients from the SUNY Upstate Medical Center Pediatric Oncology Long-term Survivor Clinic who were subjects in the original Georg Fund supported study will comprise the patient population if they are locatable and willing to participate.
- Patients must be less than 40 years of age to participate.
Who cannot join
- Patients who have received interval treatment for Acute Lymphocytic Leukemia (ALL) and those who have received subsequent cranial irradiation or total body irradiation (groups already known to be at high risk for osteoporosis) will be excluded. These would have had to have occurred in the interval since the original study, as these were also exclusion criteria for that study. In addition, any patient who received interval non-autologous bone marrow transplant will be excluded, as these patients may have graft versus host disease (also known to be associated with osteopenia).
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University
Syracuse, New York, 13202
About this study
Specific subgroups of children who survive treatment for childhood malignancies have been shown to develop relative osteopenia following chemotherapy and are felt to be at risk for developing osteoporosis later in life due to their inability to reach peak bone mass during childhood. Based upon an earlier study in our department, the investigators reported conclusive evidence that approximately half of survivors of pediatric solid malignancies are at risk for these problems. However, the proportion of patients in our population that showed osteopenia/osteoporosis was lower than that in other similar cross-sectional studies in solid tumors such as osteosarcoma. The main difference between our report and the osteosarcoma study was duration of follow-up, with ours being shorter. Longer follow-up may prove that a larger proportion of our patients are affected. The purpose is to perform a longitudinal follow-up study of bone mineral density using dual-energy X-ray absorptiometry (DXA) in adult survivors of solid pediatric tumors that were previously studied as subjects in our original cross-sectional study. The primary hypothesis is that the proportion of pediatric solid cancer survivors with significantly lower bone mineral density (BMD) compared to established age group controls will be increased with the additional time that has elapsed since the original study despite the fact that the patients are young and would not normally be expected to have osteopenia/osteoporosis at this age.
Read the detailed description
AS ABOVE
- Conditions
- Osteoporosis
- Keywords
- Examine the risk of osteoporosis in survivors of solid pediatric cancers
- Medical subject headings
- Osteoporosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome Measure:pediatric solid tumor survivors are at an increased risk for developing generalized or regional osteoporosis as a result of chemotherapy for pediatric solid tumors.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2008 (estimated)
- Study startJan 2006
- Primary completionMay 2013
- Study completionMay 2013
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
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Damron, M.D., State University of New York - Upstate Medical University
- Investigators
- Timothy A Damron, MD, Principal investigator, SU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00615485
- Sponsor's protocol ID
- Solid Pediatric Cancers
- Other IDs
- Joseph C. Georg Fund
- Status last verified
- May 2013
- First submitted
- 1 Feb 2008
- Last updated
- 30 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study of Bone Mineral Density in Survivors of Solid Pediatric Cancers
- ClinicalTrials.gov ID
- NCT00615485
- Acronym / sponsor ID
- Solid Pediatric Cancers
- Conditions
- Osteoporosis
- Keywords
- Examine the risk of osteoporosis in survivors of solid pediatric cancers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 14 Feb 2008 (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.
Specific subgroups of children who survive treatment for childhood malignancies have been shown to develop relative osteopenia following chemotherapy and are felt to be at risk for developing osteoporosis later in life due to their inability to reach peak bone mass during childhood. Based upon an earlier study in our department, the investigators reported conclusive evidence that approximately half of survivors of pediatric solid malignancies are at risk for these problems. However, the proportion of patients in our population that showed osteopenia/osteoporosis was lower than that in other similar cross-sectional studies in solid tumors such as osteosarcoma. The main difference between our report and the osteosarcoma study was duration of follow-up, with ours being shorter. Longer follow-up may prove that a larger proportion of our patients are affected. The purpose is to perform a longitudinal follow-up study of bone mineral density using dual-energy X-ray absorptiometry (DXA) in adult survivors of solid pediatric tumors that were previously studied as subjects in our original cross-sectional study. The primary hypothesis is that the proportion of pediatric solid cancer survivors with significantly lower bone mineral density (BMD) compared to established age group controls will be increased with the additional time that has elapsed since the original study despite the fact that the patients are young and would not normally be expected to have osteopenia/osteoporosis at this age.
Detailed description
AS ABOVE
Study design
Who may qualify
- Ages
- 7 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The 38 patients from the SUNY Upstate Medical Center (Syracuse, NY) Pediatric Oncology Long-term Survivor Clinic who were subjects in the original Georg Fund supported study will comprise the patient population if they are locatable and willing to participate. Patients must be less than 40 years of age to participate.
Key inclusion criteria (2 listed)
- The 38 patients from the SUNY Upstate Medical Center Pediatric Oncology Long-term Survivor Clinic who were subjects in the original Georg Fund supported study will comprise the patient population if they are locatable and willing to participate.
- Patients must be less than 40 years of age to participate.
Key exclusion criteria (1 listed)
- Patients who have received interval treatment for Acute Lymphocytic Leukemia (ALL) and those who have received subsequent cranial irradiation or total body irradiation (groups already known to be at high risk for osteoporosis) will be excluded. These would have had to have occurred in the interval since the original study, as these were also exclusion criteria for that study. In addition, any patient who received interval non-autologous bone marrow transplant will be excluded, as these patients may have graft versus host disease (also known to be associated with osteopenia).
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
Outcome Measure:pediatric solid tumor survivors are at an increased risk for developing generalized or regional osteoporosis as a result of chemotherapy for pediatric solid tumors.
Time frame: 3 years
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 30 May 2013.
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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.
Timothy A Damron, MD principal investigator
SU
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, run by State University of New York - Upstate Medical University 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 1 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 30 May 2013. 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.
What does the primary outcome measure?
Outcome Measure:pediatric solid tumor survivors are at an increased risk for developing generalized or regional osteoporosis as a result of chemotherapy for pediatric solid tumors. (time frame: 3 years). It is what the study was designed to measure, not a finding.
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 30 May 2013.