Zoledronate Early to Hip Fracture Patients - Safe and Effective? (NCT05025293) | Clinical Trial Compass
CompletedPhase 4
Zoledronate Early to Hip Fracture Patients - Safe and Effective?
Norway228 participantsStarted 2021-12-15
Plain-language summary
To prevent hip fracture patients for having another fracture, secondary fracture preventing medication should be given as soon as possible. Zoledronate is the most efficient bisphosphonate and is given as an intravenous infusion once yearly. However, the appropriate time to initiate zoledronate treatment after a hip fracture has not yet been established. To clarify the optimal timing of zoledronate to hip fracture patients we have designed a double-blinded, placebo-controlled randomized non-inferiority trial to compare if zoledronate administered early (within 5 days) after hip fracture surgery is as good as zoledronate given late (3 months) after hip fracture surgery.
Who can participate
Age range
50 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:
* Low energy hip fracture
* Surgery within 72 hours
* \>50 years old norwegian
* Women age 50-60 must be postmenopausal or not pregnant
* Acceptable kidney function (estimated GFR \>=35) and calcium levels
* Fit to complete the follow-up judged by the recruiting physician
* Signed informed consent by the patient or the next of kin
Exclusion Criteria:
* Metal in the opposite hip
* Anti-osteoporosis treatment with bisphosphonates, denosumab, teriparatide, abaloparatide or romosozumab within the last 10 years
* Glucocorticoid therapy
* Too sick to receive treatment with zoledronate judged by the recruiting or treating physician
* Any other contraindication listed on the SmPC of the IMP(s) including pregnancy
* Participating in another trial that might affect the current study
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
Difference between the two groups (ZOLearly vs ZOLlate) in proportion of patients having P1NP>35µg/L 12 months after treatment with zoledronate
Timeframe: 12 months after treatment with zoledronate