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临床试验/NCT02518763
NCT02518763Unknown3 期

Vitamin D Supplementation in Postmenopausal Women With Osteoporosis: Proposal of a Therapeutic Regimen in Practice

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2011年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
120
试验地点
1
主要终点
Serum 25 OH vitamin D concentration

研究概览

简要总结

The vitamin D deficiency (25OHD) is very common and affects about 80% of the population of French osteoporotic women over 50 years [5]. It contributes significantly to bone fragility and consequently the risk of fracture. To remedy this deficit, it is necessary to provide a suitable and sustainable supplementation. Changes in vitamin D deficiency ranging from undetectable to a 25OHD value very close to 30ng / ml lead to differences in therapeutic regimens, specific to each clinician in the absence of precise data in the literature. No consensus on supplementation dosages and methods have been proposed so far. Also, given the frequency of vitamin D deficiency including osteoporosis observed in the population, it became necessary to establish a single, uniform regimen for all patients with osteoporosis

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Postmenopausal women ≥ 50 years
  • Osteoporosis with BMD T-score ≤ -2.7DS -2.5DS to at least one of the two main sites analyzed, with or without fracture
  • having signed an informed consent

排除标准

  • Taking a "loading dose" of vitamin D in the last six months (a daily intake in combination with calcium will not be a cause of exclusion but should be discontinued during the study).
  • Taking an osteoporosis treatment combined with vitamin D in the same tablet (or Adrovance Fosavance * *)
  • Treatment with thiazide diuretic
  • Known malabsorption (celiac disease)
  • Scalable Endocrine disorders: hyperthyroidism, hyperparathyroidism, hypoparathyroidism.
  • Persistent or nephrolithiasis occurred in the previous 5 years
  • known sarcoidosis
  • Persons under guardianship or trusteeship
  • Hypercalcemia and hypercalciuria
  • 25OH vitamin D levels> 50ng / ml

研究组 & 干预措施

Vitamin D3, 100 000 IU weekly, 4 times

Experimental

干预措施: Vitamin D3, 100 000 IU weekly, 4 times (Drug)

Vitamin D3, 100 000 IU weekly, 4 times

Experimental

干预措施: 25 OH vitamin D serum concentration measurements (Biological)

结局指标

主要结局

Serum 25 OH vitamin D concentration

时间窗: 4 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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