Incidence of Osteoporosis in Children With Acute Lymphoblastic Leukemia Undergoing Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
Hypothesis:
Pediatric patients with acute lymphoblastic leukemia, treated with chronic glucocorticoids as a part of the leukemia treatment protocol, will have an increased incidence and severity of osteoporosis.
详细描述
Osteoporosis is a disease characterized by low bone mass and microarchitectural deterioration of bone tissue. Osteoporosis is a devastating disorder with significant physical, psychosocial and financial consequences. Intensive chemotherapy and radiotherapy have led to significant improvements in long term, disease-free survival of children with malignancies. Unfortunately, there are many deleterious side effects associated with this therapy. Little is known about the longitudinal changes in bone mass accumulation and bone metabolism in these patients.
The purpose of this study is to evaluate the timing and severity of changes in bone mineral metabolism for children treated for childhood leukemia. Data will be used to establish treatment protocols with the goal of preventing severe fractures and pain in the acute treatment stage and severe osteoporosis and related pathology in the chronic stage.
研究设计
- 研究类型
- Observational
- 观察模型
- Defined Population
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All pediatric patients with a new diagnosis of ALL between ages 4-18
- •Patients who are expected to receive glucocorticoids as part of the leukemia treatment protocol
- •Bone density measurements must be performed at the diagnosis visit or maximally within 48 hours after the first dose of glucocorticoids
排除标准
- •Patients under 4 years of age are excluded due to lack of age appropriate standards for bone mineral density
- •Glucocorticoid therapy of at least one month or longer within the six months prior to DX
- •History of connective tissue or musculoskeletal disorders
- •Biphosphonate therapy within the past 6 months
- •Acute renal failure
- •Serum creatinine equal to or higher than 4.5mg/dl
- •Positive serum pregnancy test in adolescent females