Bone Mineral Density Status in Pediatric and Adolescent Survivors of Childhood Cancer With History of Bone Fracture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Volumetric BMD of distal radius
研究概览
简要总结
This research study is evaluating bone mineral density in childhood cancer survivors who have a history of bone fracture.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.)
排除标准
- •Current treatment with bisphosphonates (as of time of enrollment)
- •Current treatment with the anticonvulsant depakote (at time of enrollment)
- •Currently pregnant
结局指标
主要结局
Volumetric BMD of distal radius
时间窗: 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
时间窗: 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)
次要结局
- 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)
研究者
Lynda Vrooman, MD
Principal Investigator
Dana-Farber Cancer Institute