Prosthetic loosening of hip and knee arthroplasty
Conditions
Interventions
Trade Name: zoledronic acid fresenius kabi
Product Name: Zoledronic acid fresenius kabi
Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion
Pharmaceutical form of the plac
Sponsors
Region Östergötland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients eligible for a primary hip or knee prosthesis for any form of osteoarthritis, at all ages between 18 and 80. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 700
Exclusion criteria
Exclusion criteria: • Previous or present use of bisphosphonates or other antiresorptives • Present use of other drugs which influence bone, e.g. anti-osteoporotic agents glucocorticoids (more than 5mg per day), anti-epileptics, or use less than a year before randomization • Present use of nephrotoxic medication • Active malignant disease • Pregnancy and breast feeding • Previous radiation therapy • Metabolic disease (other than osteoporosis) affecting the skeleton • Rheumatic disease • Hypocalcemia as defined by local lab criteria • Simultaneous bilateral surgery • Communication problems (drug abuse, language or behavior problems) • Creatinine clearance (GFR) <35 mL/min • Regular use of corticosteroids more than 5 mg dexamethasone per day. • Atypical fracture or osteonecrosis of the jaw • Expected follow-op period less than 3 years (e.g. due to uncontrolled malignancy) • Expected to require special postoperative surveillance due to increased surgical risk (e.g. for cardiac, psychiatric condition) • Participation in another clinical trial involving medication within 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The ultimate purpose of the study is to investigate if postoperative bisphosphonate treatment can reduce the risk of late prosthetic loosening in patients operated with primary hip- and knee arthroplasty due to osteoarthritis.;Secondary Objective: To investigate if peroperative bisphosphonate treatment affects radiographic outcome variables at 3 and 6 years after the index surgery. Other secondary objectives are changes in KOOS/HOOS from baseline to 6 years and SF36 at 1, 3 and 6 years. In exploratory analyses we aim to analyze subgroups for gender and implant types. We will also analyze the distribution of the KOOS and HOOS questionnaire to explore if the control group contains a higher proportion of patients with a poor result. ;Primary end point(s): Primary endpoint: Change in KOOS/HOOS from baseline until 3 year follow up. The treatment effect will also be estimated separately for knee and hip implants as part of explanatory analyses.;Timepoint(s) of evaluation of this end point: 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The main secondary objective is to evaluate signs of radiographic loosening at 3 and 6 years. Other secondary objectives are changes in KOOS/HOOS from baseline to 6 years and SF36 at 1, 3 and 6 years. In exploratory analyses we aim to analyze subgroups for gender and implant types. We will also analyze the distribution of the KOOS and HOOS questionnaire to explore if the control group contains a higher proportion of patients with a poor result. ;Timepoint(s) of evaluation of this end point: 3 and 6 years after the index surgery | — |
Countries
Sweden
Contacts
Public ContactJörg Schilcher
Region Östergötland
Outcome results
None listed