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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04861142
• Other study ID #: 3224
• Status: Recruiting
• Start date: April 23, 2021
• Est. completion date: October 2024

Study information

• Verified date: April 2021
• Source: University General Hospital of Heraklion
• Contact: Theodoros Tosounidis, Assistant Professor
• Phone: +30 2810395055
• Email: ttosounidis[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: October 2024
• Est. primary completion date: May 2024
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

-Patients with hip fractures after high energy falls

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Anti-osteoporotic medication( alendronate or denosumab)
Initiation of anti-osteoporotic medication (alendronate or denosumab)

Locations

Country	Name	City	State
Greece	University Hospital of Heraklion	Heraklion	Crete

Sponsors (1)

Lead Sponsor	Collaborator
University General Hospital of Heraklion

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to the prescribed anti-osteoporotic medication		1 year
Primary	Secondary fracture incidence		1 year
Secondary	Morbidity and mortality of operatively treated hip fractures in our department		1 year