ZEBRA
Zoledronate early to hip fracture patients - safe and effective? A double-blind randomized controlled treatment strategy trial on zoledronate in hip fracture patients
Project managers
Project employee
ABOUT THE PROJECT
Improve the prevention of new fractures in patients with hip fractures.
The project will clarify whether it is appropriate to wait with zoledronic acid treatment until the fracture has started to heal, or whether the effect of the treatment is just as good if it is given during the first admission. The effect of zoledronic acid is assessed by measuring a bone marker called P1NP. The main outcome is the P1NP value in patients 1 year after they have received zoledronic acid infusion either during admission for the hip fracture or 3 months after the hip fracture. Other outcomes include the number of new fractures, bone mineral density measured by DXA, duration of hospitalization for the hip fracture, antibiotic use, registration of all side effects, other admissions or contact with healthcare, function and health outcomes.
Oslo University Hospital is the data controller.
WHO CAN JOIN?
Patients over 50 years of age with a hip fracture after a fall from their own height with normal kidney function and surgery for a hip fracture within 72 hours of the fracture. Patients are included locally from the hip fracture reception center at Diakonhjemmet Hospital.
Patients who have established osteoporosis, treatment for osteoporosis within the past 10 years, previous hip fracture (metal in the opposite hip), treatment with glucocorticoids, multiple fractures or contraindication to zoledronic acid treatment cannot participate in the ZEBRA study
WHAT DOES THE STUDY INVOLVE?
The study is being conducted at Oslo University Hospital Ullevål, Bærum Hospital, Vestre Viken and Diakonhjemmet Hospital. Participants in the study will be divided into two groups by randomization, where one group will receive zoledronic acid during the hospital stay while the other group will receive zoledronic acid 3 months after the fracture at an outpatient consultation. The study is blinded for the first 3 months. Patients will receive an infusion of saline during admission to the hospital if they are in the group that receives zoledronic acid late (at the 3-month check-up). During admission for the hip fracture, a bone density measurement (DXA scan) will be performed, various measures of health status will be recorded (4AT, CAS and temperature) as for all patients. All participants in the study will also receive vitamin D and calcium as recommended in the national guideline from the Norwegian Orthopaedic Association ( www.lavenergibrudd.no ). The follow-up of the participants in both groups is the same.
At the 3-month follow-up, the participants' function and health outcomes will be assessed, as well as the status of the hip fracture. After that, the blinding will be lifted and patients who received saline during admission for the hip fracture will receive an infusion of zoledronic acid. 6 months after the infusion, there will be a new check-up with a blood test and a telephone check-up – this check-up is the only one that comes in addition to the usual follow-up after a hip fracture. 12 months after the zoledronic acid infusion, the participants will have a DXA measurement, blood test, assessment of function and health outcomes.
After completion of the Zebra study, all participants will undergo follow-up for their osteoporosis in the same way as all other patients at Diakonhjemmet Hospital.