Combined Drug Therapy in Lateral Fragility Fractures of the Femur

NCT05183308 | Completed

• 1 other identifier: Femur-Clodronic Acid
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Femur Fracture

Keywords

fragility lateral femoral fractures; bisphosphonates; clodronic acid; bone density

Outcome Measures

Primary Outcomes (1)

• 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).

  Day 1; Month 12 (after surgey)

Study Arms (2)

patients treated with Vitamin D

patients treated with Vitamin D and Clodronic Acid

Drug: Clodronic Acid

Interventions

Clodronic Acid DRUG

Osteoporotic fracture treated with surgical and medical therapy

patients treated with Vitamin D and Clodronic Acid

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Fifty (50) patients referring to the Orthopaedic and Trauma Unit of the local University Hospital between May 2019 and March 2020 with lateral fragility fracture were prospectively recruited.

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari: lead

Study Sites (1)

AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia

Bari, 70124, Italy

Location

MeSH Terms

Conditions

Femoral Fractures

Interventions

Clodronic Acid

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 10, 2022
• Study Start: May 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: February 4, 2022

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)