Primary Hyperparathyroidism: Does a Systematic Treatment Improve the Calcium- and Bone Metabolism After Successful Surgery? - Part I
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Bone mineral density measurement of the Lumbar spine
研究概览
简要总结
Patients with primary hyperparathyroidism (pHPT) with osteopenia and osteoporosis are treated with strontium ranelate/Ca+Vitamin-D or placebo/Ca+Vitamin D after successful surgical treatment of pHPT.
Strontium ranelate/Ca + Vitamin-D helps to regain bone mass in patients with osteopenia or osteoporosis after successful parathyroidectomy for pHPT and results in higher gain of BMD than placebo treated patients.
详细描述
The chronic excessive hypersecretion of parathyroid hormone (PTH) has significant impact on bone remodeling. In primary hyperparathyroidism (PHPT) bone turnover is increased, resulting in a higher resorption of bone and thus loss of bone density.
After successful surgical treatment of pHPT bone metabolism switches from catabolic state to anabolic state again. However studies show that especially postmenopausal women regain significantly less BMD but these women suffer from osteopenia and osteoporosis most often and would need to regain as much bone mass as possible to prevent fractures. The optimal state would be to reach normal BMD again. Although this state is hardly reachable especially these patients may benefit from a treatment acting anti-resorptive and rising bone formation. The only drug combining these qualities known so far is Strontium ranelate.
Therefore the hypothesis is that Strontium ranelate/Ca + Vitamin-D helps to regain bone mass in patients with osteopenia or osteoporosis after successful parathyroidectomy for pHPT and results in higher gain of BMD than placebo treated 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
- Triple (Participant, Care Provider, Investigator)
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
- •biochemically proven PHPT, PTX planned
- •osteopenia (t-score < -1 and > -2.5) or osteoporosis (t-score ≤ -2.5) according to WHO Criteria [27]
排除标准
- •Premenopausal women
- •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 hypocalciuric hypercalcaemia (Ca/creatinine ratio < 0.01)
- •Anamnestic pulmonal embolism or deep venous thrombosis
- •Blood coagulation disorder or coagulopathy
- •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
- •Known allergy against any component of the study medication
研究组 & 干预措施
Strontium Ranelate
Receiving Strontium Ranelate + Ca/Vitamin-D
干预措施: Strontium Ranelate + Ca/Vitamin-D (Drug)
Placebo
Receiving Placebo + Ca/Vitamin D
干预措施: Placebo (Drug)
结局指标
主要结局
Bone mineral density measurement of the Lumbar spine
时间窗: 1 year
次要结局
- RANKL (OPG-ligand)(1 year)
- osteocalcin (Oc)(1 year)
- phosphate (PO4-)(1 year)
- bone-specific alkaline phosphatase (BAP)(1 year)
- Bone mineral density of the femoral neck(1 year)
- ionised calcium (Ca++)(1 year)
- Osteoprotegerin (OPG/OCIF)(1 year)
- Bone mineral density of the radius(1 year)
- alkaline phosphatase (AP)(1 year)
- parathyroid hormone (PTH)(1 year)
- cathepsin K (cat K)(1 year)
研究者
Martin Niederle
MD, PhD
Medical University of Vienna