Examining Vitamin D Deficiency in Patients with Low-energy Hip Fractures 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.
This study is testing if giving vitamin D supplements to people with low-energy hip fractures can help them recover better and live longer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National and Kapodistrian University of Athens Academic / other |
| Locations | 1 site (Kifisia, Attika) |
| Trial ID | NCT06643650 on ClinicalTrials.gov |
What this trial studies
This observational study aims to document the prevalence of vitamin D deficiency in patients who have experienced low-energy osteoporotic hip fractures. It focuses on the role of vitamin D and calcium supplementation in enhancing recovery and survival rates in these patients. The study will monitor serum vitamin D levels and implement clinical pathways to guide orthopedic surgeons and primary care physicians in managing these patients effectively. Participants will receive cholecalciferol oral solution to help achieve optimal vitamin D levels.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with low-energy fractures and vitamin D levels below 30 ng/ml.
Not a fit: Patients who are pregnant, breastfeeding, or have contraindications to vitamin D supplementation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve recovery outcomes and quality of life for patients with hip fractures by addressing vitamin D deficiency.
How similar studies have performed: Other studies have indicated the importance of vitamin D in fracture recovery, suggesting that this approach may yield beneficial results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Kifisia, Attika
- KAT General Hospital of Attika — Kifisia, Attika, Greece (Recruiting)
Study contacts
- Study coordinator: Efstathios Chronopoulos, MD, MSc, PhD
- Email: stathi24@yahoo.gr
- Phone: 6944837793
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.