PHASE IV Observational Study to Document the Phenomenon of Vitamin D Deficiency and Its Added Value in Patients with Low-energy Osteoporotic Hip Fracture, in Daily Practice in Greece.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Evaluation of Vitamin D levels of the patients after receiving vitamin D supplementation
研究概览
简要总结
Vitamin D, through its action on calcium metabolism, is essential for bone physiology. Vitamin D deficiency can affect muscle function and increase the risk of falls in the elderly, while severe deficiency is common in patients with fragility fractures. Vitamin D and calcium supplementation, in addition to anti-osteoporosis treatment after surgery or conservative treatment, can ensure optimal recovery and survival, especially in patients with a hip fracture.
The goal of vitamin D supplementation is to bring the serum 25-(OH)-D concentration above 30 ng/ml.
Clinical pathways have been developed to support orthopedic surgeons in improving the medical management of patients after orthopedic/surgical fracture management. Pathways include advising primary care physicians and orthopedic surgeons on diagnostic and therapeutic approaches, promoting their appropriate use without compromising quality of care, and educating patients on non-pharmacological management of their disease (physical therapy, lifestyle habits life and nutrition).
This is an observational cohort study that will record data on the use of vitamin D in daily practice in patients with low-energy fractures.
The aim of this study is to measure vitamin D levels in the patient and provide these patients according to daily practice with appropriate supplementation for a period of one year, observing if there is a good functional outcome and a reduction in the risks of new fractures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients > 18 years old
- •Patients with a low energy fracture
- •Vitamin D levels < 30 ng/ml
- •Patients with available medical history before and after initiation of study treatment
- •Patients providing informed consent for this study
排除标准
- •Pregnant or breastfeeding women
- •Patients receiving different osteoporosis treatment
- •Patients with known hypersensitivity to vitamin D
- •Patients participating in another similar study at the same time with other drugs
- •Patients with vitamin D contraindications according to the medical instructions for use
- •Patients with a fracture due to a traffic accident
结局指标
主要结局
Evaluation of Vitamin D levels of the patients after receiving vitamin D supplementation
时间窗: 1 month, 3 months, 6 months and 12 months
Measurement of 25(OH)D vitamin
Evaluation of BMD of the patients after receiving vitamin D supplementation
时间窗: 12 months
Measurement of Bone Mineral Density
次要结局
- PTH(1 month, 3 months, 6 months and 12 months)
- TSH(1 month, 3 months, 6 months and 12 months)
- Ca(1 month, 3 months, 6 months and 12 months)
- P(1 month, 3 months, 6 months and 12 months)
- ALP(1 month, 3 months, 6 months and 12 months)
- Al(1 month, 3 months, 6 months and 12 months)
- Mg(1 month, 3 months, 6 months and 12 months)
研究者
EFSTATHIOS CHRONOPOULOS
Professor of Orthopaedic Surgery
National and Kapodistrian University of Athens
