Vitamin D Supplementation in Postmenopausal Women With Osteoporosis: Proposal of a Therapeutic Regimen in Practice
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
- 否
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
干预措施: Vitamin D3, 100 000 IU weekly, 4 times (Drug)
Vitamin D3, 100 000 IU weekly, 4 times
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
