Combined Drug Therapy in Lateral Fragility Fractures of the Femur (NCT05183308) | Clinical Trial Compass
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 range
60 Years – 85 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Visual Analogic Scale
Timeframe: Day 1; Month 12 (after surgey)
Trial details
NCT IDNCT05183308
SponsorAzienda Ospedaliero-Universitaria Consorziale Policlinico di Bari