The Effect of Combined Drug Therapy in Lateral Fragility Fractures of the Femur:a Clinical Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change in Visual Analogic Scale
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 60 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
patients treated with Vitamin D and Clodronic Acid
Intervention: Clodronic Acid (Drug)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
No secondary outcomes reported