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

NCT ID: NCT04861142

Last Updated: 2021-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-23

Study Completion Date

2024-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoporosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients adherent to the anti-osteoporotic medication

Anti-osteoporotic medication( alendronate or denosumab)

Intervention Type DRUG

Initiation of anti-osteoporotic medication (alendronate or denosumab)

Patients non-adherent to the anti-osteoporotic medication

Anti-osteoporotic medication( alendronate or denosumab)

Intervention Type DRUG

Initiation of anti-osteoporotic medication (alendronate or denosumab)

Interventions

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Anti-osteoporotic medication( alendronate or denosumab)

Initiation of anti-osteoporotic medication (alendronate or denosumab)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

-Patients with hip fractures after high energy falls
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University General Hospital of Heraklion

OTHER

Sponsor Role lead

Responsible Party

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Ioannis Daskalakis

Orthopaedic surgery resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ioannis Daskalakis, Orthopaedic Surgery Resident

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Heraklion

Theodoros Tosounidis, Assistant Professor

Role: STUDY_DIRECTOR

University Hospital of Heraklion

Apostolos Karantanas, Professor

Role: STUDY_CHAIR

University Hospital of Heraklion

Georgios Kontakis, Professor

Role: STUDY_CHAIR

University Hospital of Heraklion

Locations

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University Hospital of Heraklion

Heraklion, Crete, Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Theodoros Tosounidis, Assistant Professor

Role: CONTACT

[email protected]
+30 2810395055

Ioannis Daskalakis, Orthopaedic Surgery Resident

Role: CONTACT

[email protected]
+30 6973324328

Facility Contacts

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Theodoros Tosounidis, Assistant Professor

Role: primary

[email protected]
+30 2810395055

Other Identifiers

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3224

Identifier Type: -

Identifier Source: org_study_id

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