Comparison of the Effect of an Ongoing Treatment With Alendronate or a Drug Holiday on the Fracture Risk in Osteoporotic Patients With Bisphosphonate Long Term Therapy
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 436
- 试验地点
- 1
- 主要终点
- Number of New Osteoporotic Fractures
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of bisphosphonates in long term treatment of osteoporosis.
详细描述
Is a continued treatment with alendronate for another two years after a preceding therapy with bisphosphonates of at least four years able to reduce the incidence of new osteoporotic fractures in patients at high fracture risk compared to a therapy-free interval?
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women or men > 60 years
- •DXA T-Score at lumbar spine, total hip or femur neck <-2,0 before the start of the bisphosphonate therapy or at baseline or at least one low trauma vertebral fracture grade 2-3 or multiple low trauma vertebral fractures independent of bone mineral densitiy
- •Pretreatment with bisphosphonates for at least four years
- •Risk for hip and vertebral fractures min. 30% according to DVO-guideline for osteoporosis 2009
- •Signed informed consent
排除标准
- •Other pharmacological treatment of osteoporosis during the last 48 months
- •Other bone diseases
- •Malabsorption syndromes
- •Renal insufficiency with a calculated creatinine clearance < 35 ml/min
- •Diseases of the esophagus, delayed esophageal clearance
- •UUnability to realise the intake instructions
- •Hypocalcemia
研究组 & 干预措施
Alendronate
干预措施: Alendronate (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of New Osteoporotic Fractures
时间窗: From baseline to study termination (mean duration 5.6 months)
Number of new osteoporotic fractures. All fractures which occurred without high impact trauma (i.e. atraumatically, minor accidents and falls from standing height and lower) were regarded as osteoporotic fractures, except for fractures of fingers, face, skull and toes.
次要结局
- Combination of New Osteoporotic Fractures and Deaths(From baseline to study termination (mean duration 5.6 months))
- Mortality(From baseline to study termination (mean duration 5.6 months))
研究者
Prof. Dr. med. Johannes Pfeilschifter
Head of Department of Internal Medicine III
Evangelisches Krankenhaus Lutherhaus gGmbH