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

NCT04861142 | Unknown

• 1 other identifier: 3224
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (2)

• Adherence to the prescribed anti-osteoporotic medication

  1 year

• Secondary fracture incidence

  1 year

Secondary Outcomes (1)

• Morbidity and mortality of operatively treated hip fractures in our department

  1 year

Study Arms (2)

Patients adherent to the anti-osteoporotic medication

Drug: Anti-osteoporotic medication( alendronate or denosumab)

Patients non-adherent to the anti-osteoporotic medication

Drug: Anti-osteoporotic medication( alendronate or denosumab)

Interventions

Anti-osteoporotic medication( alendronate or denosumab) DRUG

Initiation of anti-osteoporotic medication (alendronate or denosumab)

Patients adherent to the anti-osteoporotic medication; Patients non-adherent to the anti-osteoporotic medication

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Patients with hip fractures after high energy falls

Sponsors & Collaborators

• University General Hospital of Heraklion: lead

Study Sites (1)

University Hospital of Heraklion

Heraklion, Crete, 71500, Greece

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ioannis Daskalakis, Orthopaedic Surgery Resident

  University Hospital of Heraklion

  PRINCIPAL INVESTIGATOR

• Theodoros Tosounidis, Assistant Professor

  University Hospital of Heraklion

  STUDY DIRECTOR

• Apostolos Karantanas, Professor

  University Hospital of Heraklion

  STUDY CHAIR

• Georgios Kontakis, Professor

  University Hospital of Heraklion

  STUDY CHAIR

Central Study Contacts

Theodoros Tosounidis, Assistant Professor

CONTACT

+30 2810395055; ttosounidis@yahoo.com

Ioannis Daskalakis, Orthopaedic Surgery Resident

CONTACT

+30 6973324328; g_dask@hotmail.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic surgery resident

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 27, 2021
• Study Start: April 23, 2021
• Primary Completion: May 1, 2024
• Study Completion: October 1, 2024
• Last Updated: April 27, 2021

Record last verified: 2021-04

Locations

GR (1)