NCT06643650

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.

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.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: National and Kapodistrian University of Athens · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vitamin D Deficiency
• Osteoporosis
• Bone Loss, Age-Related
• Fracture of Hip

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	CHOLECALCIFEROL 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.

Timeline

• Start date: 2022-03-11
• Primary completion: 2025-03-01
• Completion: 2025-05-01
• First posted: 2024-10-16
• Last updated: 2024-10-16

Locations

1 site across 1 country: Greece