Combined Drug Therapy in Lateral Fragility Fractures of the Femur

January 21, 2022 updated by: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy, 70124
        • AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients treated with Vitamin D
patients treated with Vitamin D and Clodronic Acid
Drug: Clodronic Acid
Osteoporotic fracture treated with surgical and medical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Day 1; Month 12 (after surgey)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

December 21, 2021

First Submitted That Met QC Criteria

January 6, 2022

First Posted (Actual)

January 10, 2022

Study Record Updates

Last Update Posted (Actual)

February 4, 2022

Last Update Submitted That Met QC Criteria

January 21, 2022

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Femur-Clodronic Acid

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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