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临床试验/EUCTR2013-001064-27-BE
EUCTR2013-001064-27-BE进行中(未招募)1 期

Placebo-controlled trial with vitamin D to prevent worsening/relieve aromatase inhibitor-induced musculoskeletal symptoms in breast cancer patients

niversity Hospitals Leuven0 个研究点目标入组 64 人开始时间: 2013年3月26日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
64

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
Female

入选标准

  • Caucasian vitamin D deficient (<30ng/ml) postmenopausal breast cancer patients treated with an aromatase inhibitor (for minimum 8 weeks) and experiencing musculoskeletal symptoms
  • 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 40
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 24

排除标准

  • Hormone replacement therapy last 6 months
  • Current use or in the last 12 months of bisphosphonates
  • Tamoxifen use in last 6 months
  • History of kidney stones
  • History of hypercalcemia/hypercalciuria or hyperthyroidism
  • Paget’s disease of the bone
  • Current use of Digitalis/digoxin or thiazide diuretics
  • Current use of vitamin D (or multivitamin) supplementation should be stopped
  • Serum 25OHD levels < 10ng/ml

研究者

发起方
niversity Hospitals Leuven

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