Bone Mineral Density in Adult Survivors of Solid Pediatric Cancers
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||Cross-sectional Study of Bone Mineral Density in Adult Survivors of Solid Pediatric Cancers|
- Osteoporosis after chemotherapy [ Time Frame: April 2003-April 2006 ] [ Designated as safety issue: No ]Does chemotherapy increase the risk of osteoporosis in patients
|Study Start Date:||April 2003|
|Study Completion Date:||April 2006|
|Primary Completion Date:||April 2006 (Final data collection date for primary outcome measure)|
Subjects who have undergone chemotherapy will receive DXA scan
Radiation: DXA Scan
The patients will undergo total body, spine, proximal femoral, and forearm DEXA testing in a standardized fashion. Patients who have undergone limb surgery or irradiation to an extremity for local disease control will also undergo selected site DEXA or pQCT scanning, depending upon the site, of the affected extremity and the identical site on the contra-lateral extremity.
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. However, currently, there is no conclusive evidence that survivors of pediatric solid malignancies are at risk for these problems due to small numbers of patients analyzed. Our SUNY Upstate Medical University Pediatric Oncology Long-term Follow-up Clinic has recently established a coalition of other upstate New York cancer centers which allows access to a large number of these patients. The purpose is to perform a cross-sectional study of bone mineral density using dual-energy X-ray absorptiometry (DEXA) in adult survivors of solid pediatric tumors. The primary hypothesis is that pediatric solid cancer survivors will demonstrate significantly lower bone mineral density (BMD) compared to established age group controls. Identification of these patients as high risk for development of osteoporosis will allow clinical trials using novel and established agents.
This study has been ongoing for 5 years. To date there have been no problems with the conduct of this study. A total of 38 subjects that have been enrolled. Analysis of research to date reveals that solid tumor survivors are at increased risk for early osteopenia/osteoporosis. No subjects have withdrawn or been excluded for any reason other than inclusion/exclusion criteria since inception of the study. The study will be ongoing for recruitment of subjects and analysis.
There was one amendment made to the protocol. The amendment was to increase the upper age of the subjects to 40 years. This amendment was made due to that although our multivariate analysis showed a relationship with number of chemotherapy drugs, our statistical power to examine according to multiple other variables, such as individual diagnosis, was limited by the relatively small numbers of patients.
An article was submitted to the Journal of Pediatric Hematology Oncology and printed in the May 2005 issue.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00634816
|United States, New York|
|SUNY Upstate Medical University|
|Syracuse, New York, United States, 13202|
|Principal Investigator:||Timothy A Damron, MD||State University of New York - Upstate Medical University|