Effects of Denosumab on Bone Microarchitecture After Total Knee Arthroplasty
Single Dose Subcutaneous Injections of Denosumab for Patients Underwent Cemented Total Knee Arthroplasty. A Randomized Controlled Study on the Effects on Bone Microarchitecture, Skeletal Muscle, Cartilage and Synovium
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
This study evaluates single dose of Denosumab in decreasing systemic and periprosthetic bone resorption after Total Knee Arthroplasty compared to placebo in 60 patients (30 placebo and 30 Denosumab) within 2 months after surgery. This study also evaluates the anti-RANKL effect of single dose of Denosumab in serum, skeletal muscle, synovium, fat, and cartilage.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2022
CompletedFirst Posted
Study publicly available on registry
September 29, 2022
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedSeptember 29, 2022
September 1, 2022
1.2 years
September 25, 2022
September 28, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Bone Microarchitecture
Bone Microarchitecture on microCT
8 weeks
Bone turnover markers
βCTXI, NTXI, 25(OH)VD3, CT, BGP, PINP
8 weeks
Secondary Outcomes (3)
intermuscular and intramuscular adipose
8 weeks
Mankin Histological-Histochemical Grading of Cartilage
8 weeks
Histopathological grading of synovium
8 weeks
Other Outcomes (1)
Certain protein expression in bone, muscle, synovium and cartilage
8 weeks
Study Arms (2)
Denosumab
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
1 ml (60 mg) subcutaneous injection Denosumab give in the posterior part of the upper arm after TKA
1 ml (60 mg) subcutaneous injection Saline give in the posterior part of the upper arm after TKA
Eligibility Criteria
You may qualify if:
- Patients with Bilateral Knee Osteoarthritis treated with Staged Bilateral Total Knee Arthroplasty, with an Interval of 8 weeks
You may not qualify if:
- Patients allergies to Denosumab Patients with previous Osteoporosis treatment Patients with renal failure Patients with previous Bisphosphonate treatment for more than 5 years Patients failed to finish contralateral Total Knee Arthroplasty at 8 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
September 25, 2022
First Posted
September 29, 2022
Study Start
October 1, 2022
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
September 29, 2022
Record last verified: 2022-09