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

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

Detailed Description
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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).

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

Conditions
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Bone Mineral Density, Childhood Cancer Survivors

Intervention / Treatment
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* Other: Dual energy x-ray absorptiometry (DXA)
* Other: Peripheral quantitative computed tomography (pQCT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DXA and pQCT Scan<br>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)<br>* Subjects will undergo DXA scan to assess total body (less head) and lumbar spine bone mineral density.<br>Other: Peripheral quantitative computed tomography (pQCT)<br>* Subjects will undergo pQCT assessment of radius and tibia.<br>|

What is the study measuring?
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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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone mineral density, Childhood cancer survivors