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Combined Drug Therapy in Lateral Fragility Fractures of the Femur

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05183308
Enrollment
50
Registered
2022-01-10
Start date
2019-05-01
Completion date
2020-03-01
Last updated
2022-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femur Fracture

Keywords

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

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.

Interventions

Osteoporotic fracture treated with surgical and medical therapy

Sponsors

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to 85 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Visual Analogic ScaleDay 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).

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026