Primary Hyperparathyroidism: Does a Systematic Treatment Improve the Calcium and Bone Metabolism After Successful Surgery in Patients Without Osteoporosis?
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Parathyroid hormone
研究概览
简要总结
Primary Hyperparathyroidism (pHPT) increases bone turnover and resorption and thus calcium efflux out of bone. After successful surgical treatment of pHPT, bone takes up calcium again which may result in secondary hyperparathyroidism or even "hungry bone syndrome". Until today there are no studies about this problem helping to develop recommendations or guidelines how to prevent these symptoms.
Study hypothesis: Calcium and vitamin D intake after surgery for PHPT protects the bone by keeping PTH in the normal range (less secondary, reactive hyperparathyroidism), prevents hungry bone- syndrome and improve bone-turnover markers (osteoporosis protection).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women
- •Male patients
- •Biochemically proven PHPT, PTX planned
- •No evidence for osteoporosis
排除标准
- •Postoperative hypocalcemia needing substitution with calcium and vitamin D/ 1-25-OH-Vitamin D
- •Cancer (lung, breast, prostatic, parathyroid cancer and thyroid carcinoma >1cm)
- •Persisting or recurrent PHPT (postoperative hypercalcemia)
- •Four-gland hyperplasia
- •Multiple endocrine neoplasia (MEN) or hereditary PHPT
- •Familial hypercalciuric hypercalcaemia (Ca/creatinine ratio < 0.01)
- •Phenylketonuria
- •Renal impairment (creatinine clearance <30ml/h)
- •Severe hepatic disorder
- •Severe systemic disorder
- •Thyroid dysfunction
- •Immobilisation
- •Intake of drugs with potential effects on BMD like glucocorticoids, lithium, estrogen-replacement therapy, selective Estrogen-receptor modulators (sERMs), bisphosphonates in the last three months
- •Intake of drugs containing digoxin or digitoxin
- •Known allergy against any component of the study medication
研究组 & 干预措施
Calcium and vitamin D
Intervention
干预措施: Calcium and vitamin D (Drug)
结局指标
主要结局
Parathyroid hormone
时间窗: 1 year
次要结局
- BMD of lumbar spine, femoral neck and radius(1 year)
- Adverse effects calcium or vitamin D(1 year)
- Other biochemical markers of bone metabolism(1 year)
研究者
Philipp Riss
Assistent Professor
Medical University of Vienna