Combined Drug Therapy in Lateral Fragility Fractures of the Femur

Sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari (Other)

Overall Status

Completed

CT.gov ID

NCT05183308

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Femur Fracture	Drug: Clodronic Acid

Study Design

Study Type:

Observational

Actual Enrollment :

50 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

The Effect of Combined Drug Therapy in Lateral Fragility Fractures of the Femur:a Clinical Study

Actual Study Start Date :

May 1, 2019

Actual Primary Completion Date :

Mar 1, 2020

Actual Study Completion Date :

Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
patients treated with Vitamin D
patients treated with Vitamin D and Clodronic Acid	Drug: Clodronic Acid Osteoporotic fracture treated with surgical and medical therapy

Arm

Intervention/Treatment

patients treated with Vitamin D

patients treated with Vitamin D and Clodronic Acid

Drug: Clodronic Acid

Osteoporotic fracture treated with surgical and medical therapy

Outcome Measures

Primary Outcome Measures

Change in Visual Analogic Scale [Day 1; Month 12 (after surgey)]
The Hip Pain was quantified using the Visual Analogic Scale ranging between 0 (no pain) and 10 points (worst imaginable pain).

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.