CompletedNot Applicable

Combined Drug Therapy in Lateral Fragility Fractures of the Femur

Italy50 participantsStarted 2019-05-01

Plain-language 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.

Who can participate

Age range60 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in Visual Analogic Scale

Timeframe: Day 1; Month 12 (after surgey)

Trial details

NCT IDNCT05183308

SponsorAzienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-03-01

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