Combined Drug Therapy in Lateral Fragility Fractures of the Femur

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Status: Completed

Conditions: Femur Fracture

Treatments: Drug: Clodronic Acid

Study type: Observational

Funder types: Other

Identifiers

NCT05183308

Femur-Clodronic Acid

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 60 to 85 years old

Volunteers: No 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.

Trial design

50 participants in 2 patient groups

patients treated with Vitamin D

patients treated with Vitamin D and Clodronic Acid

Treatment:

Drug: Clodronic Acid