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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05559268

Enrollment

Registered

2022-09-29

Start date

2022-10-01

Completion date

2023-12-31

Last updated

2022-09-29

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

Conditions

Osteoarthritis, Knee

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.

Interventions

DRUGDenosumab 60 MG/ML Injectable Solution [Prolia]

1 ml (60 mg) subcutaneous injection Denosumab give in the posterior part of the upper arm after TKA

DRUGPlacebo

1 ml (60 mg) subcutaneous injection Saline give in the posterior part of the upper arm after TKA

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 75 Years

Healthy volunteers

Inclusion criteria

Patients with Bilateral Knee Osteoarthritis treated with Staged Bilateral Total Knee Arthroplasty, with an Interval of 8 weeks

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Bone Microarchitecture	8 weeks	Bone Microarchitecture on microCT
Bone turnover markers	8 weeks	βCTXI, NTXI, 25(OH)VD3, CT, BGP, PINP

Secondary

Measure	Time frame	Description
intermuscular and intramuscular adipose	8 weeks	intermuscular and intramuscular adipose on biopsy slice
Mankin Histological-Histochemical Grading of Cartilage	8 weeks	Mankin Histological-Histochemical Grading of Cartilage
Histopathological grading of synovium	8 weeks	Histopathological grading of synovium

Other

Measure	Time frame	Description
Certain protein expression in bone, muscle, synovium and cartilage	8 weeks	Certain protein expression in bone, muscle, synovium and cartilage

Contacts

Primary ContactShuai Xiang, M.D,

15169093669@163.com+86-18661809209

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026