A Randomized, Placebo-controlled, Double-blind, Two-center Study with Denosumab in Subjects Undergoing Elective Total Knee Replacement Surgery

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000693-57-SE

Enrollment

Registered

2011-10-05

Start date

2011-11-29

Completion date

Unknown

Last updated

2018-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with idiopathic osteoarthritis of the knee, scheduled for a cemented total knee prosthesis

Interventions

Trade Name: Prolia Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Man or postmenopausal woman • 55-80 years of age • Idiopathic osteoarthritis of the knee • Scheduled for a cemented total knee prosthesis • Signed informed consent given 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: • Previous or present use of bisphosphonates • Present use of other drugs which influence bone, e.g. anti-osteoporotic agents, glucocorticoids, anti-epileptics, or use less than a year before randomization • Cardiac disease limiting physical activities; ASA class 3 or 4 • Active malignant disease • Previous radiation therapy • Metabolic disease (other than osteoporosis) affecting the skeleton. • Rheumatic disease • Hypocalcemia • Hypersensitivity to Prolia or to any of the excipients • Simultaneous bilateral surgery • Communication problems (drug abuse, language or behavior problems).

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effect of denosumab compared with placebo regarding the maximal total point motion by radiostereometric assay (MTPM by RSA) at one year.;Secondary Objective: To compare denosumab with placebo regarding translation and rotation in relation to the x, y and z axes the day after operation and after 6 months, 1 year, 2 years and 4 years. To compare denosumab with placebo regarding patient reported function using the KOOS questionnaire after 1, 2 and 4 years. To compare the treatments regarding MTPM by RSA after 2 and 4 years. To compare safety and tolerance of denosumab compared with placebo during the study period. ;Primary end point(s): The primary efficay variable is the maximal total poimt motion by radiostereometric assay (MTPM by RSA) at one year.;Timepoint(s) of evaluation of this end point: 1 year	—

Measure

Time frame

Main Objective: To evaluate the effect of denosumab compared with placebo regarding the maximal total point motion by radiostereometric assay (MTPM by RSA) at one year.;Secondary Objective: To compare denosumab with placebo regarding translation and rotation in relation to the x, y and z axes the day after operation and after 6 months, 1 year, 2 years and 4 years. To compare denosumab with placebo regarding patient reported function using the KOOS questionnaire after 1, 2 and 4 years. To compare the treatments regarding MTPM by RSA after 2 and 4 years. To compare safety and tolerance of denosumab compared with placebo during the study period. ;Primary end point(s): The primary efficay variable is the maximal total poimt motion by radiostereometric assay (MTPM by RSA) at one year.;Timepoint(s) of evaluation of this end point: 1 year

—

Secondary

Measure	Time frame
Secondary end point(s): Knee injury and Osteoarthritis Outcome Score (KOOS) at 12 months and a combination of the RSA variables at 12 months.;Timepoint(s) of evaluation of this end point: 12 months	—

Countries

Sweden

Contacts

Public ContactHåkan Ledin

Håkan Ledin

hakan.ledin@lio.se460101037030

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026