Secondary Prevention of Osteoporosis in Women Over 50 Years Old After Low Intensity Fracture of the Upper Limb: Evaluation of an Intervention Focused on the Patient.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 436
- 试验地点
- 2
- 主要终点
- Proportion of women in the 2 groups who initiated a management of osteoporosis at 6 months (BMD or osteoporosis treatment prescription).
研究概览
简要总结
Osteoporosis is a disease characterized by reduced bone mass and increased skeletal fragility, predisposing to an increased fracture risk. The presence of a low trauma fracture is a powerful predictor of future fractures and about 50% of patients with a fragility fracture will suffer a subsequent fracture in the next 10 years (Center Jacqueline R, 2007). Osteoporotic fractures are associated with an increased morbidity and mortality but also high financial costs. However, less than 20% of patients presenting a low trauma fracture receive an appropriate post-fracture osteoporosis management (Little and Eccles, 2010). The hypothesis of a lack of information and an under assessment of consequences by both patients and physicians has been raised to explain this gap between recommended care and usual practices.
The aim of the PREVOST program is to assess the efficiency of patient-centered osteoporosis prevention program, after a fragility fracture of the upper limb, to improve post-fracture management of osteoporosis (ie BMD test and / or osteoporosis treatment) in women over 50 years old.
This open randomized controlled trial aims to compare the BMD or osteoporosis treatment prescription rate at 6 months after inclusion between two groups: "intervention" receiving information on fracture and osteoporosis (oral and written), phone call reminders and written information to give to their family physician, and "control" receiving usual care without information.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged over 50 years
- •with a fragility fracture of wrist or humerus that occurred in the past 6 months
- •treated in an emergency department or orthopedic department
- •who signed the consent form
排除标准
- •no signed consent
- •previous history of femoral neck fracture
- •poly-trauma or accident
- •patients under osteoporosis treatment
- •patients who performed a BMD test in the past 6 months
- •patients with severe renal impairment, hyperthyroidism, bone primary or secondary malignancy.
- •legal disability
- •difficulty in understanding French
- •psychiatric disorder
研究组 & 干预措施
Intervention
Osteoporosis prevention program: Women will receive oral and written information and advices on osteoporosis, a letter and a leaflet on osteoporosis management to give to their family physician, and phone call reminders.
干预措施: Osteoporosis prevention program (Behavioral)
Control
Control women will receive usual post-fracture care without information
结局指标
主要结局
Proportion of women in the 2 groups who initiated a management of osteoporosis at 6 months (BMD or osteoporosis treatment prescription).
时间窗: 6 months after inclusion
At 6 months, women will be asked whether or not they received a BMD test prescription and/or an osteoporosis treatment prescription by their physician.
次要结局
- Proportion of women in the two groups who changed their behaviour in order to prevent future fractures: regular practice of physical activity, dairy products consumption and calcium and vitamin D supplementation.(6 months after inclusion.)
- Proportion of women in the two groups who performed BMD at 6 months(6 months after inclusion)
- Proportion of women in the two groups with an increased perception of fracture risk.(6 months after inclusion)
- Proportion of women who improved their knowledge about osteoporosis(6 months after inclusion)