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.

National and Kapodistrian University of Athens

Status: Enrolling

Conditions: Osteoporosis; Fracture of Hip; Vitamin D Deficiency; Bone Loss, Age-Related

Treatments: Dietary Supplement: CHOLECALCIFEROL ORAL.SOL 25000 IU/2,5ML

Study type: Observational

Funder types: Other

Identifiers

NCT06643650

945/11-03-2022

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 2 patient groups

1st group: 3 months intake of cholecalciferol supplementation (therapeutic dose)

Treatment:

Dietary Supplement: CHOLECALCIFEROL ORAL.SOL 25000 IU/2,5ML

2nd group: 3 months therapeutic and 3 months prophylactic dose intake of cholecalciferol

Treatment:

Dietary Supplement: CHOLECALCIFEROL ORAL.SOL 25000 IU/2,5ML