Longitudinal Study of Bone Mineral Density in Survivors of Solid Pediatric Cancers
2 other identifiers
observational
38
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2006
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 1, 2008
CompletedFirst Posted
Study publicly available on registry
February 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedMay 30, 2013
May 1, 2013
7.3 years
February 1, 2008
May 29, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 years
Eligibility Criteria
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.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SUNY Upstate Medical University
Syracuse, New York, 13202, United States
Biospecimen
bone specific alkaline phosphatase n-telopeptide
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy A Damron, MD
SU
Study Design
- Study Type
- observational
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 1, 2008
First Posted
February 14, 2008
Study Start
January 1, 2006
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
May 30, 2013
Record last verified: 2013-05