跳至主要内容
临床试验/EUCTR2008-001704-23-AT
EUCTR2008-001704-23-AT进行中(未招募)1 期

Primary hyperparathyroidism: does a systematic treatment improve the calcium and bone metabolism after successful surgery? – Part IISystematic treatment of patients with neither osteopenia nor osteoporosis after successful surgical treatment for primary hyperparathyroidism with Calcium and Vitamin D

Medizinische Universität Wien, Universitätsklinik für Chirurgie0 个研究点目标入组 80 人开始时间: 2009年8月18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
80

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

  • postmenopausal women
  • male patients
  • biochemically proven PHPT, PTX planned
  • no evidence for osteoporosis or osteopenia (normal BMD)
  • 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
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Cancer (including thyroid or parathyroid cancer)
  • Persisting or recurrent PHPT (postoperative hypercalcemia)
  • Four-gland hyperplasia
  • Multiple endocrine neoplasia (MEN) or hereditary PHPT
  • Familial hypercalcuric hypercalcaemia (Ca/creatinine ratio < 0.01)
  • Phenylketonuria
  • Renal impairment (creatinine clearence <30ml/h)
  • Severe hepatic disorder
  • Severe systemic disorder
  • Thyroid dysfunction
  • Concomittant thyroid surgery
  • Immobilisation
  • Intake of drugs with potential effects on BMD like glucocorticoids, lithium, estrogen-replacement therapy, selective Estrogen-receptor modulators (sERMs), bisphosphonates in the last three months
  • Intake of drugs containing digoxin or digitoxin
  • Known allergy against any component of the study medication

研究者

发起方
Medizinische Universität Wien, Universitätsklinik für Chirurgie

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