HRT and/or Etidronate in the Prevention and Treatment of Osteoporosis and Fractures in Post-Menopausal Patients With Asthma Receiving Long-Term Oral and/or Inhaled Glucocorticoids:a Randomised Factorial Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 750
- 试验地点
- 4
- 主要终点
- New symptomatic fractures, new or worsening morphometric fractures of the throaco-lumbar spine, and changes in bone mineral density.
研究概览
简要总结
To determine and compare the effects of Hormone replacement therapy (HRT), etidronate, HRT plus etidronate and no treatment over 5 years in the prevention and treatment of glucocorticoid-induced osteoporosis and fractures in post-menopausal women with asthma.
详细描述
Multicentre trial involving 13 hospitals in United Kingdom, with patients entered by 17 Consultant Chest Physicians. Consenting patients were randomised in a central office to either HRT, etidronate, HRT plus etidronate or no treatment. Information on the progress of the patients was requested by the co-ordinating office annually for 5 years after entry to the trial. Outcomes were measured as new symptomatic fractures,new or worsening morphometric fractures of the thoraco-lumbar spine and changes in bone mineral density.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 59 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal, asthmatic outpatients under 60 years of age on long-term oral or inhaled glucocorticoid treatment for at least one year.
排除标准
- •Hysterectomy, history of breast or endometrial cancer, undiagnosed pelvic or breast mass, untreated hypertension.
结局指标
主要结局
New symptomatic fractures, new or worsening morphometric fractures of the throaco-lumbar spine, and changes in bone mineral density.
次要结局
- Unwanted effects