CALCIUM CITRATE vs CALCIUM CARBONATE FOR THE MANAGEMENT OF CHRONIC HYPOPARATHYROIDISM
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change in serum calcium level
研究概览
简要总结
Hypoparathyroidism is an endocrinopathy characterized by a deficient secretion or action of PTH associated with low calcium level. According to the European guideline (2015), standard treatment includes oral calcium salts and active vitamin D metabolites to relieve symptoms of hypocalcaemia, maintain serum calcium levels in the low normal range and improve the patient's QoL Calcium carbonate is most often used and less expensive than other calcium preparations and contains the highest concentration of elemental calcium per gram (42%). It requires gastric hydrochloric acid to form carbonic acid (H2CO3) that immediately decomposes into water (H2O) and carbon dioxide (CO2). CO2 is responsible for its side effects such as flatulence, constipation and general gastrointestinal disorders. Therefore, in some patients it is better to find an alternative to calcium carbonate. Calcium citrate should be recommended to patients with achlorhydria or on treatment with proton pump inhibitors (PPI) as well as to patients who preferred to take supplements outside mealtimes. furthermore, patients with hypoparathyroidism have an increased risk of kidney stones. Kidney stones are formed by calcium salts, among which the most frequent ones are calcium-oxalate (70-80%), followed by calcium-phosphate and uric acid. Citrate salts are widely used in the treatmentof nephrolithiasis, since have shown an inhibitory effect on kidney stone formation. Up to now, there are no studies aimed to investigate the efficacy of calcium citrate in the management of subjects with chronic hypoparathyroidism. In particular, we will investigate if calcium citrate compared to calcium carbonate does not affect the risk of renal stones, if it is able to maintain normal calcium levels and, if it has an impact on QOL, in subjects with chronic hypoparathyroidism.
详细描述
BACKGROUND Hypoparathyroidism is an endocrinopathy characterized by a deficient secretion or action of PTH associated with low calcium level. It can be primary (inadequate PTH activity), or secondary (peripheral resistance to PTH).
The most common cause of chronic Hypoparathyroidism is the postsurgical one: it is usually secondary to previous thyroid surgery but may also occur following parathyroidectomy or other cervical surgical procedures. Transient Hypoparathyroidism occurs in 30-60% of patients undergoing total or subtotal thyroidectomy. About 60-70% of cases of postoperative hypocalcaemia resolve within 4-6 weeks after surgery. About 15-25% of patients will develop chronic Hypoparathyroidism. The risk of chronic Hypoparathyroidism is closely related to the number of parathyroid glands remaining in situ at operation.
Hypocalcemia is defined as serum calcium level (albumin adjusted total calcium or ionized calcium) below the lower limit of the reference range (target range).
In literature there are not data that suggest which is the best serum calcium level to maintain during treatment, but the aim is to maintain serum calcium level in the lower part or slightly below the lower limit of the reference range (adjusted serum calcium level <2.1-2.3 or S-Ca2+ between 1.05-1.15mmol/L), serum phosphate levels within the reference range, serum calcium-phosphate product below 4.4 mmol2/l2 (55 mg2/dl2), 24-hurinary calcium excretion <7.5 mmol/2h (300 mg/24h) in men, <6.25 mmol/24h (250 mg/24h) in women, or <0.1 mmol/kg per 24 h (4 mg/kg per 24h) in both sexes.
In addition to hypocalcemia, patients affected by chronic hypoparathyroidism have a higher risk of renal implications such as urolithiasis and renal impairment because lack of PTH reduces calcium absorption and phosphate excretion causing hypercalciuria and hyperphosphatemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of postsurgical chronic hypoparathyroidism by at least 6 months
- •No change of treatment over the last 3 months prior to enrollment.
- •Values of serum calcium and phosphorus stable over the last three months prior to enrollment
- •Absence of symptoms from hypocalcaemia in the 3 months prior to enrollment
- •A requirement for active vitamin D (calcitriol ≥0.25 mcg daily) and oral calcium (≥1000 mg daily) treatment.
排除标准
- •liver failure
- •renal failure (gfr <30 ml/min)
- •hypercalcemia
- •hyperthyroidism
- •parathyroid disorders
- •use of the following drugs within 3 months of the study: diuretics, bisphosphonates, calcitonin, corticosteroids, anabolic steroids, anticonvulsants, H2 receptor antagonists or proton pump inhibitor
- •heavy smokers (>10 cigarettes/day)
- •abusing alcohol (>70 ml/day)
研究组 & 干预措施
calcium Citrate
Calcium Citrate
干预措施: Calcium Citrate (Drug)
Calcium Carbonate
Calcium Carbonate
干预措施: Calcium Carbonate (Drug)
Calcium Carbonate
Calcium Carbonate
干预措施: Calcium Citrate (Drug)
calcium Citrate
Calcium Citrate
干预措施: Calcium Carbonate (Drug)
结局指标
主要结局
Change in serum calcium level
时间窗: 0, 1 and 2 months
albumin-adjusted calcium levels
Change in calcium oxalate saturation
时间窗: 0, 1 and 2 months
24-h urinary calcium oxalate saturation
次要结局
- Change in Quality of life and fatigue(0,1,2 months)
研究者
Andrea Palermo
Principal Investigator
Campus Bio-Medico University