Osteoporosis drugs to improve migration in patients with uncemented joint replacementof the hip

Phase 1

• Conditions: Prosthetic migration in uncemented total hip replacement; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2016-004960-20-SE
• Lead Sponsor: Region Östergötland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-22
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

•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

Study & Design

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