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

Sponsor
University General Hospital of Heraklion (Other)
Overall Status
Recruiting
CT.gov ID
NCT04861142
Collaborator
(none)
350
1
41.3
8.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Anti-osteoporotic medication( alendronate or denosumab)

Study Design

Study Type:
Observational
Anticipated Enrollment :
350 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Osteoporosis Treatment Protocol in Patients With Fragility Fractures: Application and Efficacy
Actual Study Start Date :
Apr 23, 2021
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm 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)

Outcome Measures

Primary Outcome Measures

  1. Adherence to the prescribed anti-osteoporotic medication [1 year]

  2. Secondary fracture incidence [1 year]

Secondary Outcome Measures

  1. Morbidity and mortality of operatively treated hip fractures in our department [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Patients with hip fractures after low-energy falls(fragility fractures)
Exclusion Criteria:

-Patients with hip fractures after high energy falls

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital of Heraklion Heraklion Crete Greece 71500

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ioannis Daskalakis, Orthopaedic surgery resident, University General Hospital of Heraklion
ClinicalTrials.gov Identifier:
NCT04861142
Other Study ID Numbers:
  • 3224
First Posted:
Apr 27, 2021
Last Update Posted:
Apr 27, 2021
Last Verified:
Apr 1, 2021
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2021