Primary Hyperparathyroidism in Patients Older Than 65 Years: A Prospective Randomized Trial of Surgical Treatment Compared With Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Region Skane
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Bone density at the hip
研究概览
简要总结
General consensus and contemporary guidelines, recommend surgery for primary hyperparathyroidism (pHPT)for all patients below the age of 50, for patients with pronounced hypercalcemia and for patients with organ complications to the disease (osteoporosis and decreased renal function).
The purpose of this study is to determine if surgery for pHPT, is appropriate for patients with moderate to mild hypercalcemia older than 65 years of age.
The hypothesis of the study is that surgery for pHPT in patients older than 65 years of age, and with mild hypercalcemia, will increase bone density and hence decrease future risk for fragility fractures compared to patients with follow-up only.
详细描述
The majority of patients diagnosed and operated due to primary HPT in Scandinavia are older than 65 years of age. The vast majority of the patients have mild aberrations of serum calcium (< 1.50 mmol/l ionized calcium), and some patients may even be asymptomatic. The present trial is designed to clarify the indications for surgical treatment in this large subgroup of patients.
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
- None
入排标准
- 年龄范围
- 66 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary Hyperparathyroidism
- •No previous parathyroid surgery
- •Sporadic disease
排除标准
- •Z-score of Bone density < -2.5 SD (regardless of site)
- •Serum level of ionized calcium > 1.50 mmol/L
- •Inability to understand given information or to comply with scheduled follow-up
- •Symptoms of hypercalcaemia for which specific medical treatment has been prescribed
研究组 & 干预措施
Follow-up
Patients diagnosed biochemically and clinically with primary hyperparathyroidism who are followed only
Surgery
Patients diagnosed biochemically and clinically with primary hyperparathyroidism who are treated with parathyroid surgery
干预措施: Parathyroid surgery (Procedure)
结局指标
主要结局
Bone density at the hip
时间窗: At two years
Bone density is assessed with DEXA (dual energy x-ray absorptiometry), at the hip.
次要结局
- Cardiac function(At two years)
- Blood lipids(At two years)
- Blood pressure (systolic and diastolic)(At two years)
- Atherosclerosis(At one two years)
- Renal function(At two years)
- Bone density at the lumbar spine(At two years)
- Cognitive function(At two years)
- Oral glucose tolerance(At two years)