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Completed

NCT Number: NCT05183308

Combined Drug Therapy in Lateral Fragility Fractures of the Femur

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.

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Key information

Conditions

Femur Fracture Femoral Fractures Fractures, Bone Leg Injuries Wounds and Injuries

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia

Bari, 70124, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clodronic Acid

Drug

Osteoporotic fracture treated with surgical and medical therapy

Primary outcomes

  1. Change in Visual Analogic Scale

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 10, 2022
Registry last updated
Feb 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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