Bone Mineral Density in Adult Survivors of Solid Pediatric Cancers

NCT ID: NCT00634816

Last Updated: 2013-05-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 38 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-04-30
• Study Completion Date: 2006-04-30

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.

Detailed Description

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 No subjects have withdrawn or been excluded for any reason other than inclusion/exclusion criteria since inception of the study.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.

Conditions

Regional Osteoporosis as a Result of Chemotherapy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Chemotherapy recipients

Subjects who have undergone chemotherapy will receive DXA scan

DXA Scan

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Patients from the SUNY Upstate Medical Center Pediatric Oncology Long-term Survivor Clinic who were treated for solid tumors and lymphomas with chemotherapy beginning at age less than 16 will be recruited for participation. Patients must be less than 40 years of age to participate.

Exclusion Criteria

• Patients treated for Acute Lymphocytic Leukemia (ALL) and those who received cranial irradiation or total body irradiation (groups already known to be at high risk for osteoporosis) will be excluded. In addition, any patient who received non-autologous bone marrow transplant will be excluded, as these patients may have graft versus host disease (also known to be associated with osteopenia).

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

State University of New York - Upstate Medical University

OTHER

Sponsor Role: lead

Responsible Party

Timothy Damron, M.D.

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Timothy A Damron, MD

Role: PRINCIPAL_INVESTIGATOR

State University of New York - Upstate Medical University

Locations

SUNY Upstate Medical University

Syracuse, New York, United States

Countries

United States

Other Identifiers

Cross Sectional

Identifier Type: -

Identifier Source: org_study_id