Combined Drug Therapy in Lateral Fragility Fractures of the Femur

Femur Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05183308
• Other study ID #: Femur-Clodronic Acid
• Status: Completed
• Start date: May 1, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: December 2020
• Source: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Femoral Fractures
• Femur Fracture
• Fractures, Bone

Intervention

Drug:
• Clodronic Acid
Osteoporotic fracture treated with surgical and medical therapy

Locations

Country	Name	City	State
Italy	AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia	Bari

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)