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: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Greece
KAT General Hospital of Attika
RECRUITING
Kifissia
Contact Information
Primary
Efstathios Chronopoulos, MD, MSc, PhD
stathi24@yahoo.gr
6944837793
Time Frame
Start Date: 2022-03-11
Estimated Completion Date: 2025-05
Participants
Target number of participants: 30
Treatments
1st group: 3 months intake of cholecalciferol supplementation (therapeutic dose)
2nd group: 3 months therapeutic and 3 months prophylactic dose intake of cholecalciferol
Sponsors
Leads: National and Kapodistrian University of Athens

This content was sourced from clinicaltrials.gov