A single postoperative bisphosphonate infusion to improve patient reported function after hip or knee replacement.

Region Östergötland0 个研究点目标入组 1,000 人开始时间: 2015年7月23日最近更新: 2024年6月3日

适应症

试验速览

暂无简介。

•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

•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

发起方