RECRUITINGPhase 4INTERVENTIONAL

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

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form by the patient or the next of kin Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Zoledronic Acid 5Mg/Bag 100Ml Inj

100ml Zoledronic acid (5mg/100ml) administered intravenously

DRUG

sodium chloride

100ml NaCl 9mg/ml administered intravenously

Locations (1)

Oslo University Hospital

Oslo, Norway