EUCTR2015-005688-18-DK进行中（未招募）1 期
A randomized controlled trial of alendronate as preventive treatment against the development of gluco-corticoid-induced osteoporosis in patients being treated for malignant lymphoma - Siesta
Department of Hematology, Aalborg University Hospital0 个研究点目标入组 60 人开始时间: 2016年4月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age = 18 years. Patients who are newly diagnosed- or recurrence of
- •Malignant lymphoma (lymph node cancer), regardless of the type and expected
- •to be treated with one of the listed chemotherapy regimens.
- •Expected lifespan =2 years
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Contraindications to alendronate.
- •Patients treated with antiresorptive (incl. HRT (hormone funds
- •sub-institution)) (bisphosphonates, anti-drug therapy (denosumab)
- •strontium, selective estrogen receptor modulators, estrogens
- •used to treat postmenopauselle genes) or bone anabolic
- •drugs (eg teriparatide), lithium and anticonvulsants. Glucocortikoid
- •treatment for up to 4 weeks prior to inclusion allowed.
- •Severe renal impairment (GFR <35 ml / min.)
- •Treatment Severe hypercalcemia at diagnosis.
- •If one is not expected to undergo chemotherapy treatment
- •(Plus. Rituximab treatment).
- •Patient without understanding of patient information and the extent of
- •investigations-look.
- •Esophagusabnormaliteter which delay esophagustømning, such as
- •stricture or achalasia.
- •Inability to stand or sit upright for at least 30 minutes.
- •Patients planned autologous bone marrow transplant
研究者
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