Osteoporosis Treatment Protocol in Patients With Fragility Fractures: Application and Efficacy

April 22, 2021 updated by: Ioannis Daskalakis, University General Hospital of Heraklion
Osteoporosis and osteoporotic fractures, especially hip fractures, have a significant impact on public healthcare. Despite the fact that the patients that have suffered an osteoporotic fracture have 86% increased risk of sustaining a second osteoporotic fracture, the efforts to prevent these fractures remain inadequate. The in-hospital initiation of antiosteoporotic treatment in patients that have been admitted due to hip fracture has shown to improve treatment rates and contribute to second fracture prevention. For this purpose the Arbeitsgemeinschaft für Osteosynthesefragen (AO) Foundation has introduced an algorithm that can be used by Orthopedic surgeons for the prevention of second fracture in patients that have already suffered an osteoporotic fracture. The purpose of this thesis is to study the efficacy of this algorithm in preventing the second fracture in the greek population. The study will include patients that have been admitted in the Orthopedics department of the University Hospital of Heraklion due to hip fracture. Bone density measurement will be performed using the DXA method and antiosteoporotic treatment will be administered according to the algorithm. These patients will be included in the hip registry of the Orthopedics department and the follow-up will last for 2 years .The primary aims of the study are: a)evaluation of the adherence to the antiosteoporotic medication b)the efficacy of the adherence to the aforementioned clinical algorithm in the secondary fracture prevention in the greek population.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

350

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

  • Name: Theodoros Tosounidis, Assistant Professor
  • Phone Number: +30 2810395055
  • Email: ttosounidis@yahoo.com

Study Contact Backup

  • Name: Ioannis Daskalakis, Orthopaedic Surgery Resident
  • Phone Number: +30 6973324328
  • Email: g_dask@hotmail.gr

Study Locations

  • Greece
    • Crete
      • Heraklion, Crete, Greece, 71500
        • Recruiting
        • University Hospital of Heraklion
        • Contact:
        • Principal Investigator:
          • Ioannis Daskalakis
        • Sub-Investigator:
          • Theodoros Tosounidis
        • Sub-Investigator:
          • Apostolos Karantanas
        • Sub-Investigator:
          • Georgios Kontakis

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

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with hip fractures after low-energy falls (fragility fractures), that are operatively treated in our department.

Description

Inclusion Criteria:

  • Patients with hip fractures after low-energy falls(fragility fractures)

Exclusion Criteria:

-Patients with hip fractures after high energy falls

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
Intervention / Treatment
Patients adherent to the anti-osteoporotic medication
Drug: Anti-osteoporotic medication( alendronate or denosumab)
Initiation of anti-osteoporotic medication (alendronate or denosumab)
Patients non-adherent to the anti-osteoporotic medication
Drug: Anti-osteoporotic medication( alendronate or denosumab)
Initiation of anti-osteoporotic medication (alendronate or denosumab)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adherence to the prescribed anti-osteoporotic medication
Time Frame: 1 year
1 year
Secondary fracture incidence
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Morbidity and mortality of operatively treated hip fractures in our department
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

University General Hospital of Heraklion

Investigators

  • Principal Investigator: Ioannis Daskalakis, Orthopaedic Surgery Resident, University Hospital of Heraklion
  • Study Director: Theodoros Tosounidis, Assistant Professor, University Hospital of Heraklion
  • Study Chair: Apostolos Karantanas, Professor, University Hospital of Heraklion
  • Study Chair: Georgios Kontakis, Professor, University Hospital of Heraklion

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)

April 23, 2021

Primary Completion (ANTICIPATED)

May 1, 2024

Study Completion (ANTICIPATED)

October 1, 2024

Study Registration Dates

First Submitted

April 22, 2021

First Submitted That Met QC Criteria

April 22, 2021

First Posted (ACTUAL)

April 27, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 27, 2021

Last Update Submitted That Met QC Criteria

April 22, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3224 (Portland VA IRB)

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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