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

Completed

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

• Registration Number: NCT02355340
• Lead Sponsor: Dana-Farber Cancer Institute

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-01-23
• Study First Submitted QC: 2015-01-30
• Study First Posted: 2015-02-04
• Study Start: 2015-05
• Primary Completion: 2024-06
• Study Completion: 2024-06-07
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.)

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DXA and pQCT Scan	Dual energy x-ray absorptiometry (DXA)	* Dual energy x-ray absorptiometry (DXA): Assessment of bone mineral density * Peripheral quantitative computed tomography (pQCT): Assessment of bone mineral density
DXA and pQCT Scan	Peripheral quantitative computed tomography (pQCT)	* Dual energy x-ray absorptiometry (DXA): Assessment of bone mineral density * Peripheral quantitative computed tomography (pQCT): Assessment of bone mineral density

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States