A Pilot Study of Calcium Replacement Therapy in Postoperative Hypoparathyroidism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
研究概览
简要总结
The goal of this clinical trial is to evaluate whether a lower-dose calcium replacement therapy is non-inferior to a higher-dose regimen in preventing symptomatic hypoparathyroidism in patients following thyroidectomy. The hypothesis is:
• lower-dose calcium replacement therapy is non-inferior to higher-dose therapy in preventing symptomatic hypoparathyroidism during the first two postoperative weeks
Researchers will compare patients receiving a lower-dose calcium replacement regimen with those receiving a higher-dose regimen to assess whether the lower dose is not associated with a higher incidence of symptomatic hypoparathyroidism.
Patients who develop post-thyroidectomy hypoparathyroidism are divided into groups for calcium replacement therapy. If they are asymptomatic, they will be scheduled for a follow-up visit at two weeks after surgery. During the follow-up visit, calcium metabolism will be evaluated, and treatment adjusted if necessary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients over the age of 18 undergoing surgery involving both lobes of the thyroid gland (thyroidectomy, "near-total" thyroidectomy, subtotal thyroidectomy, and "completed" thyroidectomy)
- •Based on the first post-operative day analysis, PTH levels are below the normal range (in our hospitals 1.8-7.8 pmol/l), but not so low (below 1.06 pmol/L) as to require calcium replacement therapy with calcitriol (rocaltrol)
排除标准
- •previously diagnosed osteoporosis; the patient is already taking calcium and vitamin D supplements prior to thyroid surgery
- •renal insufficiency (eGFR < 30)
- •patients with concomitant hyperparathyroidism undergoing simultaneous thyroidectomy and parathyroidectomy for a parathyroid adenoma
研究者
Ceith Nikkolo
general surgeon, PhD
Tartu University Hospital