NCT05025293CompletedPhase 4
Zoledronate Early to Hip Fracture Patients - Safe and Effective?
Zoledronate Early to Hip Fracture Patients - Safe and Effective? A Double-blinded Randomized Controlled Treatment Strategy Trial on Zoledronate in Hip Fracture Patients
Source: ClinicalTrials.gov · Last updated 12 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 228 (actual)
- First submitted
- 18 Aug 2021
- Start date
- 15 Dec 2021
- Primary completion date
- 11 Jun 2026
- Lead sponsor
- Lene Bergendal Solberg
- Diseases
- Osteoporosis
- NCT number
- NCT05025293
- EudraCT number
- 2020-000638-17
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 228
- From 15 Dec 2021 to the primary completion date, 11 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- Metal in the opposite hip
- Any other contraindication listed on the SmPC of the IMP(s) including pregnancy
- Participating in another trial that might affect the current study
Who the study is looking for
- 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
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oslo University Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.