Skip to main content
Clinical Trials/NCT04861142
NCT04861142RecruitingNot Applicable

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

University General Hospital of Heraklion1 site in 1 country350 target enrollmentStarted: April 23, 2021Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
350
Locations
1
Primary Endpoint
Adherence to the prescribed anti-osteoporotic medication

Study Overview

Brief Summary

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Patients with hip fractures after high energy falls

Arms & Interventions

Patients adherent to the anti-osteoporotic medication

Intervention: Anti-osteoporotic medication( alendronate or denosumab) (Drug)

Patients non-adherent to the anti-osteoporotic medication

Intervention: Anti-osteoporotic medication( alendronate or denosumab) (Drug)

Outcomes

Primary Outcomes

Adherence to the prescribed anti-osteoporotic medication

Time Frame: 1 year

Secondary fracture incidence

Time Frame: 1 year

Secondary Outcomes

  • Morbidity and mortality of operatively treated hip fractures in our department(1 year)

Investigators

Sponsor
University General Hospital of Heraklion
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ioannis Daskalakis

Orthopaedic surgery resident

University General Hospital of Heraklion

Study Sites (1)

Loading locations...

Similar Trials