ZOLEDRONIC ACID for Hip fracture

Inclusion criteria

• {"criterion_text":"- One low energy hip fracture\n- Surgery within 72 hours\n- >50 years old -\tWomen age 50-60 must be postmenopausal or not pregnant\n- Acceptable kidney function (estimated GFR >35) and calcium levels\n- Fit to complete the follow-up judged by the recruiting physician\n- Signed informed consent by the patient or the next of kin"}

Exclusion criteria

• {"criterion_text":"- Metal in the opposite hip\n- More than one acute fracture (concomitant fracture in addition to hip fracture)\n- Anti-osteoporosis treatment with bisphosphonates, denosumab, teriparatid, abaloparatid or romosozumab within the last 10 years\n- Glucocorticoid therapy, treatment with gnRH-analogs, aromatase-inhibitors, primary skeletal cancer or metastasis to the skeleton\n- Too sick to receive treatment with zoledronate judged by the recruiting or treating physician\n- Any other contraindication listed on the SmPC of the IMP(s) including pregnancy\n- Participating in another trial that might affect the current study"}

Primary endpoints

• {"endpoint_text":"- Difference between the two groups in proportion of patients having P1NP>35µg/L 12 months after treatment with zoledronate","definition_or_measurement_approach":"Proportion of patients with P1NP >35 µg/L measured 12 months after zoledronate treatment (P1NP bone turnover marker)."}

Secondary endpoints

• {"endpoint_text":"- Grade of early mobilization measured by CAS score in hospital/at discharge from hospital","definition_or_measurement_approach":"CAS score measured in hospital / at discharge."}
• {"endpoint_text":"- Number of patients with delirium assessed by 4AT in hospital","definition_or_measurement_approach":"Delirium assessed by 4AT tool during hospital stay; count of patients meeting criteria."}
• {"endpoint_text":"- Difference between the two groups in proportion of patients having CTX>0.28µg/L 12 months after treatment with zoledronate","definition_or_measurement_approach":"Proportion of patients with CTX >0.28 µg/L measured 12 months after treatment (CTX bone turnover marker)."}
• {"endpoint_text":"- Change in BMD 12 months after treatment with zoledronate","definition_or_measurement_approach":"Change in bone mineral density (BMD) measured 12 months after treatment (method not specified)."}
• {"endpoint_text":"- Grade of mobilization and rehabilitation 3 months after fracture measured by TUG test","definition_or_measurement_approach":"Timed Up and Go (TUG) test at 3 months after fracture to assess mobilization and rehabilitation."}
• {"endpoint_text":"- Number of patients with fever (T> 38’C) in hospital","definition_or_measurement_approach":"Count of patients with temperature >38°C during hospital stay."}
• {"endpoint_text":"- Number of patients treated with antibiotics in hospital","definition_or_measurement_approach":"Count of patients who receive antibiotic treatment during hospital stay."}
• {"endpoint_text":"- Time to discharge from hospital after admission and after the hip fracture surgery","definition_or_measurement_approach":"Time (days/hours) from admission and from surgery to hospital discharge (exact units not specified)."}
• {"endpoint_text":"- Time to and number of readmissions to hospital (any department)","definition_or_measurement_approach":"Time to first readmission and count of hospital readmissions (any department) over follow-up period."}
• {"endpoint_text":"- Time to and number of new fractures","definition_or_measurement_approach":"Time to new fracture and count of new fractures during follow-up."}
• {"endpoint_text":"- Time to and number of deaths","definition_or_measurement_approach":"Time to death and count of deaths during follow-up."}

Norway

Earliest CTIS Part Ii Submission Date

27-05-2024

Latest Decision Or Authorization Date

19-06-2024

Processing Time Days

23

Number Of Sites

3

Number Of Participants

300

Primary sponsor

Full Name

Oslo University Hospital HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway