RecruitingPhase 4NCT05025293

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

Sponsor

Lene Bergendal Solberg

Enrollment

300 participants

Start Date

Dec 15, 2021

Study Type

INTERVENTIONAL

Conditions

Osteoporosis Hip Fractures

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.

Eligibility

Min Age: 50 Years

Inclusion Criteria7

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 Criteria6

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