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

NCT ID: NCT02355340

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2024-06-07

Brief Summary

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

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).

Conditions

Bone Mineral Density; Childhood Cancer Survivors

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Dual energy x-ray absorptiometry (DXA)

Intervention Type: OTHER

Subjects will undergo DXA scan to assess total body (less head) and lumbar spine bone mineral density.

Peripheral quantitative computed tomography (pQCT)

Intervention Type: OTHER

Subjects will undergo pQCT assessment of radius and tibia.

Interventions

Dual energy x-ray absorptiometry (DXA)

Subjects will undergo DXA scan to assess total body (less head) and lumbar spine bone mineral density.

Intervention Type: OTHER

Peripheral quantitative computed tomography (pQCT)

Subjects will undergo pQCT assessment of radius and tibia.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Lynda Vrooman, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lynda Vrooman, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Boston Children's Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

14-411

Identifier Type: -

Identifier Source: org_study_id