Longitudinal Study of Bone Mineral Density in 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:
NCT00615485
First received: February 1, 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. Based upon an earlier study in our department, the investigators reported conclusive evidence that approximately half of survivors of pediatric solid malignancies are at risk for these problems. However, the proportion of patients in our population that showed osteopenia/osteoporosis was lower than that in other similar cross-sectional studies in solid tumors such as osteosarcoma. The main difference between our report and the osteosarcoma study was duration of follow-up, with ours being shorter. Longer follow-up may prove that a larger proportion of our patients are affected. The purpose is to perform a longitudinal follow-up study of bone mineral density using dual-energy X-ray absorptiometry (DXA) in adult survivors of solid pediatric tumors that were previously studied as subjects in our original cross-sectional study. The primary hypothesis is that the proportion of pediatric solid cancer survivors with significantly lower bone mineral density (BMD) compared to established age group controls will be increased with the additional time that has elapsed since the original study despite the fact that the patients are young and would not normally be expected to have osteopenia/osteoporosis at this age.


Condition
Osteoporosis

Study Type: Observational
Official Title: Longitudinal Study of Bone Mineral Density in 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:
  • Outcome Measure:pediatric solid tumor survivors are at an increased risk for developing generalized or regional osteoporosis as a result of chemotherapy for pediatric solid tumors. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

bone specific alkaline phosphatase n-telopeptide


Enrollment: 38
Study Start Date: January 2006
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Detailed Description:

AS ABOVE

  Eligibility

Ages Eligible for Study:   7 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The 38 patients from the SUNY Upstate Medical Center (Syracuse, NY) Pediatric Oncology Long-term Survivor Clinic who were subjects in the original Georg Fund supported study will comprise the patient population if they are locatable and willing to participate. Patients must be less than 40 years of age to participate.

Criteria

Inclusion criteria:

  • The 38 patients from the SUNY Upstate Medical Center Pediatric Oncology Long-term Survivor Clinic who were subjects in the original Georg Fund supported study will comprise the patient population if they are locatable and willing to participate.
  • Patients must be less than 40 years of age to participate.

Exclusion criteria:

  • Patients who have received interval treatment for Acute Lymphocytic Leukemia (ALL) and those who have received subsequent cranial irradiation or total body irradiation (groups already known to be at high risk for osteoporosis) will be excluded. These would have had to have occurred in the interval since the original study, as these were also exclusion criteria for that study. In addition, any patient who received interval 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: NCT00615485

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 SU
  More Information

No publications provided

Responsible Party: Timothy Damron, M.D., Associate Professor, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT00615485     History of Changes
Other Study ID Numbers: Solid Pediatric Cancers, Joseph C. Georg Fund
Study First Received: February 1, 2008
Last Updated: May 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by State University of New York - Upstate Medical University:
Examine the risk of osteoporosis in survivors of solid pediatric cancers

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

ClinicalTrials.gov processed this record on August 20, 2014