Combined Drug Therapy in Lateral Fragility Fractures of the Femur

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari50 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Femur Fracture

Interventions

Clodronic AcidDRUG

Osteoporotic fracture treated with surgical and medical therapy

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in Visual Analogic Scale

The Hip Pain was quantified using the Visual Analogic Scale ranging between 0 (no pain) and 10 points (worst imaginable pain).

Time frame: Day 1; Month 12 (after surgey)