ocal zoledronate for improved fixation of uncemented hip prostheses.

Region Östergötland0 个研究点目标入组 60 人开始时间: 2016年12月22日最近更新: 2024年7月8日

适应症

试验速览

暂无简介。

•Patients 50-70 years of age with osteoarthritis of the hip in need of hip replacement. Written informed consent to participate in the study is required.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•Abnormal configuration of the acetabulum or femur making implantation of the study implants unfeasible
•Previous or present use of bisphosphonates or other antiresorptives
•Prevalent use of other drugs, which influence bone, or use less than a year before randomization.
•?Drugs with the following ATC codes will lead to exclusion of the patient
•oAntiepileptic drugs: N03AG, N03AF, N03AA, N03AB, N03AC,
•oStrontium: M05BX03
•oDenosumab: M05BX04
•oParathyroid hormone: H05
•oCorticosteroids (with a dosage equivalent to more than 5mg prednisolone): H02
•Present use of nephrotoxic medication
•Active malignant disease
•Previous radiation therapy of the hip or pelvis
•Metabolic disease (other than osteoporosis) affecting the skeleton
•Rheumatic disease
•Hypocalcemia as defined by local lab criteria (assessment is clinical routine)
•Simultaneous bilateral surgery
•Communication problems (drug abuse, language or behavior problems)
•Creatinine clearance (GFR) <35 mL/min (assessment is clinical routine)
•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

发起方