Bone Mineral Density in Adult Survivors of Solid Pediatric Cancers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Timothy Damron, M.D., State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT00634816
First received: March 4, 2008
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Regional Osteoporosis as a Result of Chemotherapy
Radiation: DXA Scan

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by State University of New York - Upstate Medical University:

Primary Outcome Measures:
  • Osteoporosis after chemotherapy [ Time Frame: April 2003-April 2006 ] [ Designated as safety issue: No ]
    Does chemotherapy increase the risk of osteoporosis in patients


Enrollment: 38
Study Start Date: April 2003
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   16 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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).
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00634816

Locations
United States, New York
SUNY Upstate Medical University
Syracuse, New York, United States, 13202
Sponsors and Collaborators
State University of New York - Upstate Medical University
Investigators
Principal Investigator: Timothy A Damron, MD State University of New York - Upstate Medical University
  More Information

No publications provided

Responsible Party: Timothy Damron, M.D., Associate Professor, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT00634816     History of Changes
Other Study ID Numbers: Cross Sectional
Study First Received: March 4, 2008
Last Updated: May 29, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 18, 2014