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.

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.

Study Overview

• Status: Recruiting
• Conditions: Vitamin D Deficiency; Osteoporosis; Bone Loss, Age-Related; Fracture of Hip
• Intervention / Treatment: Dietary supplement: CHOLECALCIFEROL ORAL.SOL 25000 IU/2,5ML

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Efstathios Chronopoulos, MD, MSc, PhD; Phone Number: 0030 6944837793; Email: stathi24@yahoo.gr

Study Locations

• Greece
  • Attika
    • Kifisia, Attika, Greece, 14561
      • Recruiting
      • KAT General Hospital of Attika
      • Contact: Efstathios Chronopoulos, Professor; Phone Number: 0030 6944837793; Email: stathi24@yahoo.gr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients older than 18 years of age with a low energy fracture will be included in the study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1st group: 3 months intake of cholecalciferol supplementation (therapeutic dose)	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.; Other Names: DELTIUS ORAL.SOL 25000 IU/2,5ML
2nd group: 3 months therapeutic and 3 months prophylactic dose intake of cholecalciferol	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.; Other Names: DELTIUS ORAL.SOL 25000 IU/2,5ML

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Vitamin D levels of the patients after receiving vitamin D supplementation	Measurement of 25(OH)D vitamin	1 month, 3 months, 6 months and 12 months
Evaluation of BMD of the patients after receiving vitamin D supplementation	Measurement of Bone Mineral Density	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTH	Measurement of blood test of Parathyroid Hormone	1 month, 3 months, 6 months and 12 months
TSH	Measurement of blood test of Thyroid-stimulating Hormone	1 month, 3 months, 6 months and 12 months
Ca	Measurement of blood test of Calcium levels	1 month, 3 months, 6 months and 12 months
P	Measurement of blood test of Phosphorus levels	1 month, 3 months, 6 months and 12 months
ALP	Measurement of blood test of Alkaline phosphatase levels	1 month, 3 months, 6 months and 12 months
Al	Measurement of blood test of Albumin levels	1 month, 3 months, 6 months and 12 months
Mg	Measurement of blood test of Magnesium levels	1 month, 3 months, 6 months and 12 months

Collaborators and Investigators

• Sponsor: National and Kapodistrian University of Athens

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2022
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: February 7, 2024
• First Submitted That Met QC Criteria: October 13, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Wounds and Injuries; Leg Injuries; Nutrition Disorders; Musculoskeletal Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Bone Diseases; Femoral Fractures; Hip Injuries; Bone Diseases, Metabolic; Vitamin D Deficiency; Fractures, Bone; Hip Fractures; Osteoporosis; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: 945/11-03-2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No