Prediction and Secondary Preventing of Fractures in a Norwegian Population. A Substudy of Norwegian Capture the Fracture Initiative
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Osteoporotic Fractures
- 发起方
- Oslo University Hospital
- 入组人数
- 840
- 试验地点
- 6
- 主要终点
- Fragility fractures
- 状态
- 已完成
- 最后更新
- 6年前
概览
简要总结
The purpose of this study is to investigate patient related factors that contribute to increased risk of recurrent fractures and to investigate patient adherence to prescribed anti-osteoporotic drugs.
详细描述
A standardized treatment program of osteoporosis will be introduced successively at 7 hospitals in Norway from April 2015 to January 2016. This Project is named NoFRACT (Norwegian Capture the Fracture Initiative https://clinicaltrials.gov/show/NCT02536898). Patients above 50 years of age, who recently have suffered a fragility fracture, will be offered examination of osteoporosis and treatment if indicated. Some of these patients will be asked to participate in this consent-based sub-study (NoFRACTsub). At baseline, the patients will be asked to answer a questionnaire, collect blood-sample for to outline possible causes for osteoporosis, in addition to Dual X-Ray Apsopiometry (DXA) scan including bone mineral density(BMD), trabecular bone score(TBS) and vertebral fracture assessment (VFA). At 1-year follow-up there will be a brief questionnaire and measuring of BTM. At 2-year follow-up there will be a brief questionnaire in addition to repeated measurement of DXA including BMD, TBS and VFA. All data will be stored securly at the designated server at the University of Oslo, Service of sensitive data, TSD.
研究者
Frede Frihagen
Consultant
Oslo University Hospital
入排标准
入选标准
- •Patients participating in NoFRACT
- •Recent low-trauma vertebral or non-vertebral fracture
- •Written patient consent
排除标准
- •Fractures of scull, face, toes or fingers
- •Short life expectancy
- •Patients not competent or willing to give consent
- •Patients having difficulties in answering questionairies, undergoing a DXA scan, and show up on the follow-ups,
结局指标
主要结局
Fragility fractures
时间窗: 2 years
Number of new fractures during observation periode
次要结局
- Trabecular Bone Score (TBS)(Baseline, 2 years)
- s-PINP(At 1 year follow-up)
- FRAX score(Baseline)
- Garvan score(Baseline)
- s-CTX(At 1 year follow-up)
- Spinal Deformity Index (SDI)(Baseline, 2 years)
- Bone mineral Density (BMD)(Baseline, 2 years)
- Self-reported adherence to anti-osteoporotic drugs (AOD)(Baseline, 1 year, 2 years)