Osteoporosis drugs to improve outcome in patients with joint replacement of the hip and knee.

Phase 1

• Conditions: Prosthetic loosening of hip and knee arthroplasty; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2015-001200-55-SE
• Lead Sponsor: Region Östergötland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-23
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1000

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified