Active vitamin D for secondary hyperparathyroidism after bariatric surgery: a multicenter randomized controlled trial (ActiVitD)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 5
- 主要终点
- Normalization of PTH (and thus recovery of secondary hyperparathyroidism) at 2 years after diagnosis and start of treatment in one of the study groups. Secondary hyperparathyroidism will be defined as PTH at the upper limit or above the labs reference value combined with a normal or decreased serum calcium level (in patients with 25(OH)D >50 nmol/L
研究概览
简要总结
To investigate the effect of alfacalcidol on the treatment of secondary hyperparathyroidism in patients after RYGB
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Men and both pre- and postmenopausal women who have had Roux-en-Y-gastric bypass surgery, aged 18 years or above, and present with secondary hyperparathyroidism after surgery, with a vitamin D sufficient state (>50 nmol/l), and only on standard supplementation, are included
- •Provide informed consent prior to any specific study procedure
排除标准
- •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
结局指标
主要结局
Normalization of PTH (and thus recovery of secondary hyperparathyroidism) at 2 years after diagnosis and start of treatment in one of the study groups. Secondary hyperparathyroidism will be defined as PTH at the upper limit or above the labs reference value combined with a normal or decreased serum calcium level (in patients with 25(OH)D >50 nmol/L
Normalization of PTH (and thus recovery of secondary hyperparathyroidism) at 2 years after diagnosis and start of treatment in one of the study groups. Secondary hyperparathyroidism will be defined as PTH at the upper limit or above the labs reference value combined with a normal or decreased serum calcium level (in patients with 25(OH)D >50 nmol/L
次要结局
- Decrease in BMD (defined as 3% decrease in T-score at the lumbar spine and 5% decrease in T-score at the hip / forearm), measured at 1 and 2 years after inclusion
- Quality of life is measured after inclusion and thereafter every 6 months with the OBESI-Q questionnaire
研究者
N.M. Appelman-Dijkstra
Scientific
Academisch Ziekenhuis Leiden