NCT00168909已完成4 期
Influence of Alfacalcidol on Falls in Elderly Postmenopausal, Alendronate-Treated, Osteopenic/Osteoporotic Women With High Risk of Falls
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 282
- 试验地点
- 2
- 主要终点
- primary outcome: number of fallers (patients with at least one locomotor fall incl.mixed falls)
研究概览
简要总结
The purpose of this study is to evaluate the effect of alfacalcidol 1 µg daily on the number of fallers in postmenopausal, alendronate-treated, osteopenic or osteoporotic women.
primary outcome = number of fallers (patients with at least one locomotor fall incl.mixed falls)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age > 65 years
- •postmenopausal women
- •osteopenia/osteoporosis as defined by WHO criteria
排除标准
- •Neoplasm or other severe diseases with life expectancy less than one year or expectation of rapid worsening within one year
- •Chronic inflammatory rheumatoid disease
- •Arthritis with continuous pain and influence on locomotion
- •Inflammatory or metabolic bone disease, excluding osteoporosis.
- •Subjects with antiosteoporotic medications who are not willing to switch over to alendronate treatment. Estrogen treatment can be continued
- •25-OH-Vitamin D3 < 12 ng/ml (12 ng/ml = 30 mmol/L)
- •Systemic corticosteroid treatments of more than one month within previous 12 months
- •Intolerability for alfacalcidol
- •Hypercalcaemia (>2,7 mmol/l)
- •Milk alkali syndrome
- •Uncorrected, severe visual impairments
- •Creatinin > 2.5 mg/dl (>220 µmol/L)
研究组 & 干预措施
1
Experimental
alfacalcidol 1µg/d
干预措施: alfacalcidol (Drug)
2
Placebo Comparator
placebo
干预措施: placebo (Drug)
结局指标
主要结局
primary outcome: number of fallers (patients with at least one locomotor fall incl.mixed falls)
时间窗: 3 years
次要结局
- secondary outcome: number of falls (locomotor falls, incl.mixed falls), all falls/fallers, neuromuscular parameters, BMD, biochemical parameters of calcium and bone metabolism; cognition and moods; muscle biopsies(3 years)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
The Effect of Alfacalcidol on Muscle Strength in Elderly Indonesian Women : A Randomized Controlled TrialMuscle WeaknessNCT02327091Indonesia University122
已完成
1 期
Dose Finding Study in Physically Frail Elderly to Measure 25(OH) Vitamin D Levels After Supplementation With Hy.D Calcifediol 25 SD/S and Vitamin D3Pre-frail ElderlyFrail ElderlyNCT01868945DSM Nutritional Products, Inc.59
Unknown
3 期
Prevention of Falls and Fractures in Old People by Administration of Calcium and Vitamin D. Randomized Clinical TrialFallFracturesNCT01452243Gerencia de Atención Primaria, Albacete704
Unknown
不适用
Fall Prevalence and Factors Affecting Falls in Elderly.FallingNCT04229641Eastern Mediterranean University499
撤回
不适用
Impact of Drugs on the Risk of Falls in the Fracture Department of the Paris Saint-Joseph Hospital GroupFallFractureNCT04470895Fondation Hôpital Saint-Joseph