NCT01841814撤回4 期
Evolution of Bone Mineral Density (BMD) in Patients With Lymphoma Undergoing Chemotherapy: Prospective Longitudinal Study Over 12 Months.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Measurement of bone mineral density (BMD).
研究概览
简要总结
The purpose of this study is to assess changes of bone mineral density (BMD) at 12 months during the therapeutic management of patients with lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 18 to 80 with lymphoma,
- •Histological diagnosis of Hodgkin's lymphoma (HL) or non-Hodgkin lymphoma (NHL) of follicular or aggressive (large cell or other),
- •Patients who have not yet started their chemotherapy or who have started for less than a month
- •Patient has signed informed consent.
排除标准
- •Pathological fractures at the time of initial diagnosis of lymphoma,
- •Compression of neurological epidural,
- •Patients receiving treatment for osteoporosis (including bisphosphonates, selective modulators of estrogen receptor, calcitonin and parathyroid hormone Teriparatide).
- •Discovery of osteoporosis or osteopenia fracture during the initial evaluation requiring the establishment of an osteoporosis treatment,
- •Radiotherapy to the lumbar spine or hip studied,
- •Location of bone lymphoma in the lumbar spine or hip studied,
- •History of disorders affecting bone metabolism (prostate cancer with androgen, stomach cancer, hyperparathyroidism, hyperthyroidism, uncontrolled ...)
- •A person incapable of giving consent personally,
- •Pregnant or breastfeeding women,
- •Protected Person (under guardianship)
- •Patient not affiliated with a social security system.
结局指标
主要结局
Measurement of bone mineral density (BMD).
时间窗: Change from Baseline of bone mineral density at 12 months.
Patients will have a review of bone densitometry.
次要结局
未报告次要终点
研究者
研究点 (2)
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