EUCTR2022-000178-24-NL招募中1 期
Active vitamin D for secondary hyperparathyroidism after bariatric surgery: a multicenter randomized controlled trial. - ActiVitD trial
未提供0 个研究点目标入组 130 人开始时间: 2023年4月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •-Men and both pre- and postmenopausal women who have had Roux-en-Y-gastric bypass surgery and present with secondary hyperparathyroidism after surgery, with a vitamin D sufficient state (>50 nmol/l), and only on standard supplementation, are included.
- •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 130
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •-Patients who are already on active treatment for osteoporosis before inclusion
- •-Patients with chronic kidney disease defined as eGFR < 60 ml/min
- •-Patients who had a bariatric intervention before and are re-operated
- •-Patients that are on chronic steroid use, for example for inflammatory conditions
- •-Patients that appear to have hypercalcemia on screening
- •-Patients with known inflammatory conditions (i.e. rheumatoid arthritis)
- •-Patients that have an active pregnancy wish
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