Combined Drug Therapy in Lateral Fragility Fractures of the Femur

NCT ID: NCT05183308

Last Updated: 2022-02-04

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

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-01

Study Completion Date

2020-03-01

Brief Summary

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It was conducted a prospective study with a series of 50 patients treated by intramedullary nail using Clodronic acid and Vitamin D (study group including 25 patients) and patients with the same fractures treated with Vitamin D alone (control group including 25 patients).

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.

Detailed Description

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Conditions

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Femur Fracture

Study Design

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Observational Model Type

OTHER

Study Time Perspective

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

Intervention Type DRUG

Osteoporotic fracture treated with surgical and medical therapy

Interventions

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Clodronic Acid

Osteoporotic fracture treated with surgical and medical therapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* femur fractures type 31-A1, A2, (Muller ME, Nazarian S, Kock P et al.);
* 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 heart, kidney, neurological diseases;
* 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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia

Bari, , Italy

Site Status

Countries

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Italy

Other Identifiers

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Femur-Clodronic Acid

Identifier Type: -

Identifier Source: org_study_id

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