NCT00491920已完成4 期
High Dosage Vitamin D in the Treatment of Osteoporosis in Postmenopausal Women
University Hospital of North Norway2 个研究点 分布在 1 个国家目标入组 297 人开始时间: 2007年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 297
- 试验地点
- 2
- 主要终点
- changes in bone mineral density in columna and total hip.
研究概览
简要总结
Vitamin D and calcium are essential in the treatment and prevention of osteoporosis. What dosage of vitamin D which is the ideal one, is not yet clear. We want to test the hypothesis that high dosage of vitamin D (i.e. 6500 IU/d) is better than standard dosage (800 IU/d) in a randomized double-blind trial. We will include 400 postmenopausal otherwise healthy women with T-score <= -2.0 in L2-4 or mean total hip. Everybody will receive calcium 1000 mg and vitamin D 800 IU every day. Half of the group will also receive vitamin D 40 000 IU/week, while the other half will have placebo. The study period is one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •bone mineral density in L2-4 or mean total hip with T-score <= -2.0
排除标准
- •current use of bisphosphonates, PTH-analogs, estrogen, SERM, p.o. steroids or use of any of these agents last year
- •serum creatinin >110 umol/L
- •systolic blood pressure >175 mmHg or diastolic blod pressure >105
- •serious disease (heart failure, angina pectoris, myocardial infarction, diabetes, mental reduction, granulomatous disease like sarcoidosis, cancer)
- •kidney stone
- •serum calcium > 2.55 mmol/L
- •suspect primary hyperparathyroidism with serum calcium >2.50 mmol/L combined with PTH > 5.0 mmol/L or serum calcium > 2.45 mmol/L combined with PTH >= 7.0 pmol/L
结局指标
主要结局
changes in bone mineral density in columna and total hip.
时间窗: One year
次要结局
- Muscle strength (hand grip strength and knee extension)(One year)
- balance (tandem test)(One year)
- body composition (Dexa)(One year)
- inflammation markers(One year)
- calcium and vitamin D metabolism(One year)
- blood lipids(One year)
- renal function(One year)
- telomere length(one year)
- perception of own health(one year)
- Urinary tract symptoms(one year)
- effects of polymorphisms in VDR on the other endpoints(one year)
- side effects(one year)
研究者
研究点 (2)
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