Zebra
Zoledronate Early to Hip Fracture Patients - Safe and Effective? A Double-Blinded Randomized Controlled Treatment Strategy Trial On Zoledronate in Hip Fracture Patients
Project managers
Project employee
ABOUT THE PROJECT
Better prevention of new fractures in patients with hip fractures.
The project will clarify whether to wait for zoledronic acid treatment until the fracture has begun to grow, or whether the effect of the treatment is equally good if it is given during the first admission. The effect of zoledronic acid is assessed with measurement of a bone marker calling P1NP. The main result is the P1NP value in patients 1 year after they have received zoledronic acid infusion either during insertion for the hip breakage or 3 months after the hip fracture. Other results include the number of new fractures, bone density measured on DXA, duration of the hospitalization for the hip fracture, antibiotic use, registration of all side effects, other admissions or contact with health care, function and health outcomes.
Oslo University Hospital is responsible for data.
WHO CAN JOIN?
Patients over 50 years of hip fractures after fall from their own height with normal kidney function and surgery for hip fractures within 72 hours from the bread time. Patients are included locally from the hip fracture reception at Diakonhjemmet hospital.
Patients who have established osteoporosis, treatment for osteoporosis for the last 10 years, previous hip fractures (metal in the opposite hip), treatment with glucocorticoids, multiple fractures or contraindication to zoledronic acid haydling cannot participate in the Zebra study
WHAT DOES THE STUDY INCLUDE?
The study is conducted at Oslo University Hospital Ullevål, Bærum Hospital, Vestre Viken and Diakonhjemmet Hospital. Participants in the study are divided into two groups using a draw where a group gets zoledronic acid during the hospital stay while the other group will have zoledronic acid 3 months after the breakup of an outpatient consultation. The study is blinded for the first 3 months. Patients will receive an infusion of salt water during the hospital insertion if they are in the group receiving zoledronic acid late (on 3 months of control). During admission to the hip fracture, there will be a bone density measurement (DXA scanning), different measures for health status are recorded (4at, CAS and temperature) as in all patients. In addition, all participants in the study will receive vitamin D and calcium as recommended in the national supervisor from the Norwegian Orthopedic Association ( www.lavenergrolfrefrol.no ). The follow -up of the participants in both groups is equal.
In 3 months of control, the participants' function and health outcomes will be assessed as well as the status of the hip fracture. Then the blinding will be abolished and patients who received salt water during insertion for the hip breakage will have an infusion of zoledronic acid. 6 months after the infusion, there is new control of blood tests and telephone control - this control is the only one that comes in addition to regular follow -up after hip fractures. 12 months after zoledronic acid infusion, participants come to a DXA measurement, blood test, assessment of function and health outcome.
After termination in the Zebra study, all participants surpass follow up on their osteoporosis on par with all other patients at Diakonhjemmet Hospital.