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

Recruiting

• Conditions: Osteoporosis
• Interventions: Drug: Anti-osteoporotic medication( alendronate or denosumab)

• Registration Number: NCT04861142
• Lead Sponsor: University General Hospital of Heraklion

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-04
• Study First Submitted: 2021-04-22
• Study First Submitted QC: 2021-04-22
• Last Update Submitted: 2021-04-22
• Study Start: 2021-04-23
• Study First Posted: 2021-04-27
• Last Update Posted: 2021-04-27
• Primary Completion: 2024-05
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

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

Exclusion Criteria

-Patients with hip fractures after high energy falls

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients non-adherent to the anti-osteoporotic medication	Anti-osteoporotic medication( alendronate or denosumab)	-
Patients adherent to the anti-osteoporotic medication	Anti-osteoporotic medication( alendronate or denosumab)	-

Primary Outcome Measures

Name	Time	Method
Adherence to the prescribed anti-osteoporotic medication	1 year
Secondary fracture incidence	1 year

Secondary Outcome Measures

Name	Time	Method
Morbidity and mortality of operatively treated hip fractures in our department	1 year

Trial Locations

Locations (1)

University Hospital of Heraklion; 🇬🇷 Heraklion, Crete, Greece