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.

October 13, 2024 updated by: EFSTATHIOS CHRONOPOULOS, National and Kapodistrian University of Athens

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluation of Vitamin D levels of the patients after receiving vitamin D supplementation
Time Frame: 1 month, 3 months, 6 months and 12 months
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
Time Frame: 12 months
Measurement of Bone Mineral Density
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PTH
Time Frame: 1 month, 3 months, 6 months and 12 months
Measurement of blood test of Parathyroid Hormone
1 month, 3 months, 6 months and 12 months
TSH
Time Frame: 1 month, 3 months, 6 months and 12 months
Measurement of blood test of Thyroid-stimulating Hormone
1 month, 3 months, 6 months and 12 months
Ca
Time Frame: 1 month, 3 months, 6 months and 12 months
Measurement of blood test of Calcium levels
1 month, 3 months, 6 months and 12 months
P
Time Frame: 1 month, 3 months, 6 months and 12 months
Measurement of blood test of Phosphorus levels
1 month, 3 months, 6 months and 12 months
ALP
Time Frame: 1 month, 3 months, 6 months and 12 months
Measurement of blood test of Alkaline phosphatase levels
1 month, 3 months, 6 months and 12 months
Al
Time Frame: 1 month, 3 months, 6 months and 12 months
Measurement of blood test of Albumin levels
1 month, 3 months, 6 months and 12 months
Mg
Time Frame: 1 month, 3 months, 6 months and 12 months
Measurement of blood test of Magnesium levels
1 month, 3 months, 6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National and Kapodistrian University of Athens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 11, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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