EUCTR2015-005303-91-IT进行中（未招募）1 期
Clinical Trial of pharmacokinetics of calcifediol (25OHD3) in women with postmenopausal osteoporosis - VIT_D_2015
AZIENDA OSPEDALIERA UNIVERSITARIA SENESE0 个研究点目标入组 50 人开始时间: 2020年11月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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
- 性别
- Female
入选标准
- •Post-menopausal women (amenorrea for at least 5 years).
- •Age between 55 and 70 years
- •Lumbar or Femoral T-score (DXA) = - 2.5 DS
- •Serum levels of 25(OH)D3 between 10 and 20 ng/ml
- •Informed Consent signed
- •Willingness and capacity to adhere to study protocol.
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •Femoral T-score (DXA) = -3.0 DS
- •History of fragility fractures
- •Osteomalacia or Paget disease of bone
- •Secondary Osteoporosis (primary or secondary hyperparathyroidism, Cushings disease,etc)
- •Treatment with oestrogen, drugs for osteoporosis or drugs known to interfere with bone metabolism (glucocorticoids, anticonvulsants, heparin, antiretrovirals etc)
- •Diabetes Mellitus Type 1 and 2
- •Neoplastic Diseases
- •BMI < 18 or >29.9 kg/m2
- •Treatment with calcifediol, calcitriol or colecalciferol in the previous 2 months
- •Mental and cognitive disorders
- •Inability or unwillingness to adhere to the study protocol
- •Refuse to sign the informed Consent.
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