Clinical trial NCT06643650: 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.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vitamin D Deficiency
Osteoporosis
Bone Loss, Age-Related
Fracture of Hip
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients older than 18 years of age with a low energy fracture will be included in the study.

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.


Eligibility 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

Primary outcomes:
measure: Evaluation of Vitamin D levels of the patients after receiving vitamin D supplementation
timeFrame: 1 month, 3 months, 6 months and 12 months
measure: Evaluation of BMD of the patients after receiving vitamin D supplementation
timeFrame: 12 months
Secondary outcomes:
measure: PTH
timeFrame: 1 month, 3 months, 6 months and 12 months
measure: TSH
timeFrame: 1 month, 3 months, 6 months and 12 months
measure: Ca
timeFrame: 1 month, 3 months, 6 months and 12 months
measure: P
timeFrame: 1 month, 3 months, 6 months and 12 months
measure: ALP
timeFrame: 1 month, 3 months, 6 months and 12 months
measure: Al
timeFrame: 1 month, 3 months, 6 months and 12 months
measure: Mg
timeFrame: 1 month, 3 months, 6 months and 12 months
Other outcomes:
Locations:
city: Kifisia
country: Greece
facility: KAT General Hospital of Attika
state: Attika
Study officials:
References: