Effects of Denosumab on Bone Microarchitecture After Total Knee Arthroplasty

NCT ID: NCT05559268

Last Updated: 2022-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Denosumab

Group Type EXPERIMENTAL

Denosumab 60 MG/ML Injectable Solution [Prolia]

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Denosumab 60 MG/ML Injectable Solution [Prolia]

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role lead

Responsible Party

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Xiang Shuai, MD

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Shuai Xiang, M.D,

Role: CONTACT

+86-18661809209

Other Identifiers

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Denosumab AHQD

Identifier Type: -

Identifier Source: org_study_id

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