EUCTR2005-004316-73-GB进行中（未招募）1 期
The effects of growth hormone, strontium ranelate and phosphate on PTH circadian rhythm, PTH target organ sensitivity, bone turnover markers, phospho-calcium metabolism and bone mineral density. A prospective, open labelled study. - Effects of anabolic therapies on PTH circadian rhythm & sensitivity
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1.Postmenopausal women(no spontaneous menses for 2years or more) >55 years with reduced BMD (T score < -1.0 on DEXA scan)
- •2.Men with reduced BMD (T score <-1.0 on DEXA)
- •3.Adult Growth Hormone Deficiency (defined as a peak GH response of less than 9mU/litre (3 microg/litre) to hypoglycaemia
- •(blood glucose <2.2mmol/litre) induced during an insulin stress test).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Abnormal PTH, calcium, phosphate, vitamin D (<10 ng/ml), testosterone, thyroid function (except stable thyroxine replacement) on baseline testing
- •Unstable angina
- •NYHA heart failure grades III and IV
- •Liver disease (liver function tests >3 times upper limit of normal)
- •Renal disease (Creatinine > 150µmol/l)
- •Patients with nephrocalcinosis (renal stone )
- •Malignant carcinomas, tumour activity, excluding basal cell carcinoma of skin
- •Previous vertebral or hip fracture
- •Ongoing treatment with corticosteroids, bisphosphonates, diuretics, calcium and vitamin D (pharmacological doses)
- •Women on HRT
- •Previous venous thromboembolism
- •Patients with uncontrolled or accelerated hypertension
- •Patients with Phenylketonuria
- •Patients who refuse to participate.
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