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

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ClinicalTrials.gov Identifier: NCT04861142
Recruitment Status : Recruiting
First Posted : April 27, 2021
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
Ioannis Daskalakis, University General Hospital of Heraklion

Study Description
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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
Osteoporosis Drug: Anti-osteoporotic medication( alendronate or denosumab)

Study Design
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Study Type : Observational
Estimated 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 : April 23, 2021
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : October 2024

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Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. Adherence to the prescribed anti-osteoporotic medication [ Time Frame: 1 year ]
  2. Secondary fracture incidence [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Morbidity and mortality of operatively treated hip fractures in our department [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with hip fractures after low-energy falls (fragility fractures), that are operatively treated in our department.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04861142


Contacts
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Contact: Theodoros Tosounidis, Assistant Professor +30 2810395055 ttosounidis@yahoo.com
Contact: Ioannis Daskalakis, Orthopaedic Surgery Resident +30 6973324328 g_dask@hotmail.gr

Locations
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Greece
University Hospital of Heraklion Recruiting
Heraklion, Crete, Greece, 71500
Contact: Theodoros Tosounidis, Assistant Professor    +30 2810395055    ttosounidis@yahoo.com   
Principal Investigator: Ioannis Daskalakis         
Sub-Investigator: Theodoros Tosounidis         
Sub-Investigator: Apostolos Karantanas         
Sub-Investigator: Georgios Kontakis         
Sponsors and Collaborators
University General Hospital of Heraklion
Investigators
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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
More Information
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Responsible Party: Ioannis Daskalakis, Orthopaedic surgery resident, University General Hospital of Heraklion
ClinicalTrials.gov Identifier: NCT04861142    
Other Study ID Numbers: 3224
First Posted: April 27, 2021    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
 Denosumab
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs