Calcium Replacement Therapy in Postoperative Hypoparathyroidism
A Pilot Study of Calcium Replacement Therapy in Postoperative Hypoparathyroidism
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.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Hanna Hollman
- 电话号码：+37259037517
- 邮箱：hanna.hollman@ut.ee
研究联系人备份
- 姓名：Ceith Nikkolo
- 电话号码：+372 53318092
学习地点
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Tartu、爱沙尼亚
- 招聘中
- Tartu University Hospital
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接触：
- Ceith Nikkolo, PhD
- 电话号码：+372 53319082
- 邮箱：ceith.nikkolo@kliinikum.ee
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Other
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Tallinn、Other、爱沙尼亚、11914
- 招聘中
- East Tallinn Central Hospital
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接触：
- Hanna Hollman, MD
- 电话号码：+ 372 59037517
- 邮箱：hanna.hollman@itk.ee
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Lower dose calcium replacement
calcium carbonate 1250 mg x 2
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One study group takes calcium carbonate 1250 mg (500 mg elemental calcium) twice a day (at lunchtime and in the evening)
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有源比较器：Higher dose calcium replacement
calcium carbonate 1250 mg x 4
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The second study group takes 1250 mg of calcium carbonate (500 mg of elemental calcium) four times a day (starting at noon, at approximately 4-hour intervals: at noon, in the early afternoon, in the evening, and before bedtime).
This dosage regimen is prescribed because 500 mg of calcium can be absorbed at a time.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Occurence of symptomatic hypoparathyroidism
大体时间：2 weeks
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Occurrence of symptomatic hypoparathyroidism within 14 days postoperatively
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2 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Serum calcium levels at 2 week follow-up
大体时间：2 weeks
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Comparison of serum calcium levels at the 2-week follow-up between lower- and higher-dose calcium replacement groups.
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2 weeks
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Duration and permanence of hypoparathyroidism
大体时间：Up to 12 months postoperatively
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Assessment of whether postoperative hypoparathyroidism resolves (transient) or persists (permanent) during follow-up.
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Up to 12 months postoperatively
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Serum parathyroid hormone (PTH) levels at 2 week follow-up
大体时间：2 weeks
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Comparison of serum parathyroid hormone (PTH) levels at the 2-week follow-up between lower- and higher-dose calcium replacement groups.
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2 weeks
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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