Trial Information

Cross-sectional Study of Bone Mineral Density in Adult Survivors of Solid Pediatric Cancers

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 No subjects have withdrawn or been excluded for any reason other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.