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Effects of Denosumab on Bone Microarchitecture After Total Knee Arthroplasty

Q

Qingdao University

Status and phase

Not yet enrolling
Phase 4

Conditions

Osteoarthritis, Knee

Treatments

Drug: Denosumab 60 MG/ML Injectable Solution [Prolia]
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05559268
Denosumab AHQD

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

50 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

60 participants in 2 patient groups, including a placebo group

Denosumab
Experimental group
Treatment:
Drug: Denosumab 60 MG/ML Injectable Solution [Prolia]
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Central trial contact

Shuai Xiang, M.D,

Data sourced from clinicaltrials.gov

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