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Longitudinal Study of Bone Mineral Density in Survivors of Solid Pediatric Cancers

Primary Purpose

Osteoporosis

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
State University of New York - Upstate Medical University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Osteoporosis focused on measuring Examine the risk of osteoporosis in survivors of solid pediatric cancers

Eligibility Criteria

7 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • SUNY Upstate Medical University

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
February 1, 2008
Last Updated
May 29, 2013
Sponsor
State University of New York - Upstate Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT00615485
Brief Title
Longitudinal Study of Bone Mineral Density in Survivors of Solid Pediatric Cancers
Official Title
Longitudinal Study of Bone Mineral Density in Survivors of Solid Pediatric Cancers
Study Type
Observational

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York - Upstate Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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. 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.
Detailed Description
AS ABOVE

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Examine the risk of osteoporosis in survivors of solid pediatric cancers

7. Study Design

Enrollment
38 (Actual)
Biospecimen Retention
Samples Without DNA
Biospecimen Description
bone specific alkaline phosphatase n-telopeptide
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Study Population Description
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.
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy A Damron, MD
Organizational Affiliation
SU
Official's Role
Principal Investigator
Facility Information:
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13202
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Longitudinal Study of Bone Mineral Density in Survivors of Solid Pediatric Cancers

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