Bone Mineral Density in Adult Survivors of Solid Pediatric Cancers

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.

Study Overview

• Status: Completed
• Conditions: Regional Osteoporosis as a Result of Chemotherapy
• Intervention / Treatment: Radiation: DXA Scan

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 No subjects have withdrawn or been excluded for any reason other than inclusion/exclusion criteria since inception of the study.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

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• United States
  • New York
    • Syracuse, New York, United States, 13202
      • SUNY Upstate Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from the Oncology Clinic by one of the sub-investigators.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chemotherapy recipients; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Osteoporosis after chemotherapy	Does chemotherapy increase the risk of osteoporosis in patients	April 2003-April 2006

Collaborators and Investigators

• Sponsor: State University of New York - Upstate Medical University
• Investigators: Principal Investigator: Timothy A Damron, MD, State University of New York - Upstate Medical University

Study record dates

Study Major Dates

• Study Start: April 1, 2003
• Primary Completion (Actual): April 1, 2006
• Study Completion (Actual): April 1, 2006

Study Registration Dates

• First Submitted: March 4, 2008
• First Submitted That Met QC Criteria: March 12, 2008
• First Posted (Estimate): March 13, 2008

Study Record Updates

• Last Update Posted (Estimate): May 30, 2013
• Last Update Submitted That Met QC Criteria: May 29, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: Cross sectional