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.

NCT06643650 | Recruiting

• 1 other identifier: 945/11-03-2022
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• PTH

  1 month, 3 months, 6 months and 12 months

• TSH

  1 month, 3 months, 6 months and 12 months

• Ca

  1 month, 3 months, 6 months and 12 months

• P

  1 month, 3 months, 6 months and 12 months

• ALP

  1 month, 3 months, 6 months and 12 months

Study Arms (2)

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

Dietary Supplement: CHOLECALCIFEROL 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

Interventions

CHOLECALCIFEROL ORAL.SOL 25000 IU/2,5ML DIETARY_SUPPLEMENT

Cholecalciferol 25000IU/week for 3 months in both groups. 2nd group continues with 25000IU/month for following 3 months.

Also known as: DELTIUS ORAL.SOL 25000 IU/2,5ML

1st group: 3 months intake of cholecalciferol supplementation (therapeutic dose); 2nd group: 3 months therapeutic and 3 months prophylactic dose intake of cholecalciferol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

KAT General Hospital of Attika

Kifissia, Attica, 14561, Greece

RECRUITING

MeSH Terms

Conditions

Vitamin D Deficiency; Osteoporosis; Hip Fractures

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Central Study Contacts

Efstathios Chronopoulos, MD, MSc, PhD

CONTACT

6944837793; stathi24@yahoo.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Orthopaedic Surgery

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: October 16, 2024
• Study Start: March 11, 2022
• Primary Completion: March 1, 2025
• Study Completion: May 1, 2025
• Last Updated: October 16, 2024

Record last verified: 2024-02

Locations

GR (1)