Bone Loss, Age-Related, Fracture of Hip, Osteoporosis, Vitamin D Deficiency
Conditions
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.
Interventions
DIETARY_SUPPLEMENTCHOLECALCIFEROL ORAL.SOL 25000 IU/2,5ML
Cholecalciferol 25000IU/week for 3 months in both groups. 2nd group continues with 25000IU/month for following 3 months.
Sponsors
National and Kapodistrian University of Athens
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Mg | 1 month, 3 months, 6 months and 12 months | Measurement of blood test of Magnesium 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 |
| P | 1 month, 3 months, 6 months and 12 months | Measurement of blood test of Phosphorus levels |
| PTH | 1 month, 3 months, 6 months and 12 months | Measurement of blood test of Parathyroid Hormone |
Countries
Greece
Contacts
Primary ContactEfstathios Chronopoulos, MD, MSc, PhD
Outcome results
None listed