Bone Mineral Density Status in Pediatric and Adolescent Survivors of Childhood Cancer With History of Bone Fracture

This research study is evaluating bone mineral density in childhood cancer survivors who have a history of bone fracture.

Study Overview

• Status: Recruiting
• Conditions: Bone Mineral Density; Childhood Cancer Survivors
• Intervention / Treatment: Other: Dual energy x-ray absorptiometry (DXA); Other: Peripheral quantitative computed tomography (pQCT)

Detailed Description

The purpose of this research study is to learn more about the status of bones in children and young-adults who have had bone fractures after treatment for childhood cancer. Bone complications including fracture can be important issues for some childhood cancer survivors. In this study we are measuring bone mineral density in children and young adults who have had bone fracture after treatment for childhood cancer. We will measure bone mineral density in two ways. We will use: 1) dual energy x-ray absorptiometry (also known as DXA), and 2) peripheral quantitative computed tomography (also known as pQCT).

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Lynda Vrooman, MD; Phone Number: (617) 632-2659; Email: lynda_vrooman@dfci.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
      • Contact: Lynda Vrooman, MD; Phone Number: 617-632-2659; Email: lynda_vrooman@dfci.harvard.edu
      • Principal Investigator: Lynda Vrooman, MD
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Dana Farber Cancer Institute
      • Contact: Lynda Vrooman, MD; Phone Number: 617-632-2659; Email: lynda_vrooman@dfci.harvard.edu
      • Principal Investigator: Lynda Vrooman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Childhood cancer survivors, currently age 8-20 with a history of bone fracture after completion of chemotherapy.

Description

Inclusion Criteria:

• History of childhood cancer
• Age ≥ 8 years and < 20 years at time of enrollment
• ≥ 2 years since completion of cancer-directed therapy for first cancer
• Received chemotherapy for treatment of childhood cancer
• History of bone fracture after the conclusion of chemotherapy*
• Not currently receiving cancer-directed therapy
• Signed written informed consent (by parent if patient is < 18 years of age, or by patient, if he or she is ≥18 years of age)
• Patient assent for those ≥10 years of age and < 18 years of age for whom a parent provides informed consent (*History of bone fracture will be based on patient/parent report of fracture occurrence and will be confirmed in review of the medical record whenever feasible.)

Exclusion Criteria:

• Current treatment with bisphosphonates (as of time of enrollment)
• Current treatment with the anticonvulsant depakote (at time of enrollment)
• Currently pregnant

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
DXA and pQCT Scan; Dual energy x-ray absorptiometry (DXA): Assessment of bone mineral density; Peripheral quantitative computed tomography (pQCT): Assessment of bone mineral density	Other: Dual energy x-ray absorptiometry (DXA); Subjects will undergo DXA scan to assess total body (less head) and lumbar spine bone mineral density.; Other: Peripheral quantitative computed tomography (pQCT); Subjects will undergo pQCT assessment of radius and tibia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total body BMD (total body less head) and lumbar spine BMD	DXA assessment (z-score)	Participants to undergo a single baseline assessment on day 1; to be measured at ≥ 2 years since completion of cancer-directed therapy
Volumetric BMD of distal radius	pQCT assessment	Participants to undergo a single baseline assessment on day 1; to be measured at ≥ 2 years since completion of cancer-directed therapy

Secondary Outcome Measures

Outcome Measure	Time Frame
25-hydroxy vitamin D level	Participants to undergo a single baseline assessment on day 1; to be measured at ≥ 2 years since completion of cancer-directed therapy

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Lynda Vrooman, MD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: January 23, 2015
• First Submitted That Met QC Criteria: January 30, 2015
• First Posted (Estimated): February 4, 2015

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 11, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Bone mineral density; Childhood cancer survivors
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 14-411