Clinical Study of Desuzumab in the Treatment of Knee Osteoarthritis

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Drug: Denosumab

• Registration Number: NCT06357741
• Lead Sponsor: Wuhan Union Hospital, China

Brief Summary

As an activator of inhibiting nuclear factor kB receptor, denosumab affects osteoclast differentiation and development by inhibiting OPG/RANKL-RANK bone regulatory axis pathway. Therefore, denosumab is widely used in the treatment of bone diseases such as osteoporosis. Osteoporosis is closely related to knee osteoarthritis. RANKL-RANK pathway also plays a ke...

Detailed Description

basic overview at present, about 60% of the elderly over 60 years old in China suffer from knee osteoarthritis, and there are more than 100million patients with knee osteoarthritis in China. It is estimated that the world's elderly population will reach 2.02 billion in 2050, and China will reach 480million, accounting for almost 5% of the global elderly popu...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2023-03-02
• Study First Submitted: 2023-08-05
• Primary Completion: 2024-02-02
• Study Completion: 2024-03-10
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-04
• Last Update Submitted: 2024-04-04
• Study First Posted: 2024-04-10
• Last Update Posted: 2024-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• patients with knee osteoarthritis whose inclusion criteria meet the "diagnostic criteria for arthritis" .
• no drug contraindications .
• aged between 45 and 75 .
• committed to follow the research procedures, And cooperate with the •implementation of the whole process study .
• the patient understands the relevant treatment process .
• the patient has the ability to give informed consent .
• The patient had not recently taken any medication that affected observation.
• the subjects must meet all the inclusion criteria to be eligible to participate in the study .

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Exclusion Criteria

• mental illness .
• patients with malignant tumors.
• patients with other infectious diseases .
• patients with metabolic bone disease, diabetes and hyperthyroidism.
• patients who cannot actively cooperate in the treatment.
• hypocalcemia.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
desumumab4	Denosumab	60mg, single injection.
desumumab5	Denosumab	60mg, single injection.
desumumab1	Denosumab	60mg, single injection.
desumumab2	Denosumab	60mg, single injection.
desumumab 3	Denosumab	60mg, single injection.
desumumab 6	Denosumab	60mg, single injection.
desumumab7	Denosumab	60mg, single injection.
desumumab 8	Denosumab	60mg, single injection.

Primary Outcome Measures

Name	Time	Method
Knee pain relief	1,3,6 months	Knee joint WOMAC score（maximum：250 ，minimum：0） at 1,3 and 6 months，The higher the score, the better the pain relief.

Trial Locations

Locations (1)

Wuhan Union Hospital; 🇨🇳 Wuhan, Hubei, China