Clinical trial NCT04861142: Osteoporosis Treatment Protocol in Patients With Fragility Fractures: Application and Efficacy
Official title: Osteoporosis Treatment Protocol in Patients With Fragility Fractures: Application and Efficacy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoporosis
Lead sponsor: University General Hospital of Heraklion
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 350
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hip fractures after low-energy falls (fragility fractures), that are operatively treated in our department.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-Patients with hip fractures after high energy falls

Primary outcomes:
measure: Adherence to the prescribed anti-osteoporotic medication
timeFrame: 1 year
measure: Secondary fracture incidence
timeFrame: 1 year
Secondary outcomes:
measure: Morbidity and mortality of operatively treated hip fractures in our department
timeFrame: 1 year
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: University Hospital of Heraklion
state: Crete
Study officials:
affiliation: University Hospital of Heraklion
name: Ioannis Daskalakis, Orthopaedic Surgery Resident
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Heraklion
name: Theodoros Tosounidis, Assistant Professor
role: STUDY_DIRECTOR
affiliation: University Hospital of Heraklion
name: Apostolos Karantanas, Professor
role: STUDY_CHAIR
affiliation: University Hospital of Heraklion
name: Georgios Kontakis, Professor
role: STUDY_CHAIR
References: