Combined Drug Therapy in Lateral Fragility Fractures of the Femur
NCT ID: NCT05183308
Last Updated: 2022-02-04
Study Results
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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COMPLETED
50 participants
OBSERVATIONAL
2019-05-01
2020-03-01
Brief Summary
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One independent observer performed clinical, biochemical and functional evaluations at T0 (1st day post-surgery) and at T1 (12 months later) Biochemical markers (serum calcium level, serum phosphate level, PTH (parathormone), Vitamin D, serum C-terminal telopeptide), VAS (Visual Analogic Scale) and HHS (Harris Hip Score) score, and femur densitometric views were administered at each evaluation.
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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patients treated with Vitamin D
No interventions assigned to this group
patients treated with Vitamin D and Clodronic Acid
Clodronic Acid
Osteoporotic fracture treated with surgical and medical therapy
Interventions
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Clodronic Acid
Osteoporotic fracture treated with surgical and medical therapy
Eligibility Criteria
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Inclusion Criteria
* age 60 - 85 years;
* co-operative patients;
* Body Mass Index (BMI) \< 30 Kg/m²;
* patients treated by intramedullary nailing surgery (PFNA Synthes®);
* patients with osteoporosis disease if T-Score\< -2,5;
Exclusion Criteria
* patients with metabolic and systemic disease (rheumatoid arthritis, diabetes mellitus);
* previous surgery or severe osteoarthritis of lower limbs;
* specific drugs treatments such as anticoagulants or psychiatric drugs.
60 Years
85 Years
ALL
No
Sponsors
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Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
OTHER
Responsible Party
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Locations
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AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia
Bari, , Italy
Countries
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Other Identifiers
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Femur-Clodronic Acid
Identifier Type: -
Identifier Source: org_study_id
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