Combined Drug Therapy in Lateral Fragility Fractures of the Femur

Completed

• Conditions: Femur Fracture
• Interventions: Drug: Clodronic Acid

• Registration Number: NCT05183308
• Lead Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-01
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01
• Status Verified: 2020-12
• Study First Submitted: 2021-12-21
• Study First Submitted QC: 2022-01-06
• Study First Posted: 2022-01-10
• Last Update Submitted: 2022-01-21
• Last Update Posted: 2022-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients treated with Vitamin D and Clodronic Acid	Clodronic Acid	-

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia; 🇮🇹 Bari, Italy