EUCTR2016-001510-20-DK进行中（未招募）1 期
Treatment of Primary Hyperparathyroidism with Denosumab and Cinacalcet - Denocina
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
入选标准
- •Men and women of 18 years of age or older.
- •T-score by DXA between -1,0 og -3,5.
- •Patients from The North Jutland Region diagnosed with primary hyperparathyroidism at departments of endocinology in hospitals of the North Jutland Region.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Medical history of diseases leading to hypercalcaemia other than Primary Hyperparathyroidism.
- •Patients being treated with Denosumab or Cinacalcet prior to inclusion.
- •Moderatly - Severely decreased liver function (ALAT >250u/l, GGT>150u/l, Bilirubin >30)
- •AMI or apoplexia within 3 months before inclusion.
- •Medical record of heartfailure.
- •Risk factors of prolonged QTc-interval.
- •Open lesions from oral surgery.
- •Primary diseases of the bone other than osteoporosis.
- •Patients suffering from kidney disease or renal failure.
- •Patients under treatment with thiazide or lithium.
- •Medical record of generalized seizures or epilepsia.
- •Active malignant disease.
- •Known allergies towards the specified IMP's.
- •Pregnancy or breastfeeding.
- •Fertile women who do not agree to the usage of effective anticonception.
- •Other circumstances, evaluated by the responsible investigator, making the subject unsuitable for participation.
研究者
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已完成
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