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.
- Conditions
- Vitamin D DeficiencyOsteoporosisBone Loss, Age-RelatedFracture of Hip
- Registration Number
- NCT06643650
- Lead Sponsor
- National and Kapodistrian University of Athens
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of Vitamin D levels of the patients after receiving vitamin D supplementation 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 12 months Measurement of Bone Mineral Density
- Secondary Outcome Measures
Name Time Method PTH 1 month, 3 months, 6 months and 12 months Measurement of blood test of Parathyroid Hormone
TSH 1 month, 3 months, 6 months and 12 months Measurement of blood test of Thyroid-stimulating Hormone
Ca 1 month, 3 months, 6 months and 12 months Measurement of blood test of Calcium levels
P 1 month, 3 months, 6 months and 12 months Measurement of blood test of Phosphorus levels
ALP 1 month, 3 months, 6 months and 12 months Measurement of blood test of Alkaline phosphatase levels
Al 1 month, 3 months, 6 months and 12 months Measurement of blood test of Albumin levels
Mg 1 month, 3 months, 6 months and 12 months Measurement of blood test of Magnesium levels
Trial Locations
- Locations (1)
KAT General Hospital of Attika
🇬🇷Kifisia, Attika, Greece