Timing of zoledronate treatment for hip fracture patients
Zoledronate Early to Hip Fracture Patients - Safe and Effective? A Double-blinded Randomized Controlled Treatment Strategy Trial on Zoledronate in Hip Fracture Patients
This study is testing whether giving a medication called zoledronate right after hip surgery can help prevent future fractures better than waiting three months to start the treatment for people over 50.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Drugs / interventions | denosumab, romosozumab |
| Locations | 1 site (Oslo) |
| Trial ID | NCT05025293 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine the optimal timing for administering zoledronate, a bisphosphonate medication, to patients who have undergone surgery for hip fractures. It is a double-blinded, placebo-controlled randomized non-inferiority trial comparing early administration (within 5 days post-surgery) to late administration (3 months post-surgery). The study focuses on preventing recurrent fractures in this high-risk population by evaluating the effectiveness of early treatment. The trial will include patients over 50 years old who have experienced low-energy hip fractures and meet specific health criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals over 50 years old who have sustained a low-energy hip fracture and are fit for follow-up.
Not a fit: Patients with contraindications to zoledronate treatment or those who have received certain osteoporosis medications in the past 10 years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved fracture prevention strategies for hip fracture patients, reducing the risk of subsequent fractures.
How similar studies have performed: Previous studies have indicated the effectiveness of zoledronate in fracture prevention, but this specific timing approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Oslo
- Oslo University Hospital — Oslo, Norway (Recruiting)
Study contacts
- Principal investigator: Solberg B Lene, PhD MD — Oslo University Hospital
- Study coordinator: Lene B Solberg, PhD MD
- Email: l.b.solberg@gmail.com
- Phone: +4797669950
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.