Clinical Study of Desuzumab in the Treatment of Knee Osteoarthritis (CSODITTOKO)

April 4, 2025 updated by: Tian Hongtao, Wuhan Union Hospital, China
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 key role in the pathogenesis of knee osteoarthritis. Therefore, the investigators propose the hypothesis that denosumab can effectively treat knee osteoarthritis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 population, making it the country with the largest elderly population in the world . At present, the treatment of knee osteoarthritis is only analgesic drugs to alleviate symptoms, and there is no effective treatment to reverse the progress of knee osteoarthritis. Therefore, many patients with knee osteoarthritis eventually face knee replacement surgery. In 2019, there were nearly 400000 knee replacement operations in China, and the number will increase by 30% next year, which is undoubtedly a huge economic expenditure for patients. Denosumab is widely used in the treatment of osteoporosis by inhibiting nuclear factor kB activating factor (rank). Rank and RANKL are important molecular systems that regulate bone remodeling and the dynamic balance of bone metabolism. In osteoporosis, the combination of rank and RANKL will directly promote the differentiation and maturation of osteoblasts, enhance their bone resorption activity and prevent their apoptosis. The relative transcription of rank in osteoclasts and their precursor cells is significantly increased, which promotes bone loss and leads to osteoporosis. RANKL-RANK pathway also plays a key role in the pathogenesis of osteoarthritis . The chondrocytes and synovial cells of patients with knee osteoarthritis will produce interleukin-1 after being stimulated by trauma, wear and tear β （IL-1 β）、 TNF- α And prostaglandin E2 (PGE2) and other inflammatory factors promote osteoclasts to secrete metalloproteinases (MMPs) and matrix protease tissue inhibitors (TIMPs), and these inflammatory factors can directly stimulate RANKL to induce the production of osteoclasts, resulting in the destruction of cartilage matrix, the impairment of bone regeneration ability, the irreversible degradation of cartilage tissue, and even apoptosis . At the same time, it has been reported in the literature that osteoporosis and knee osteoarthritis are closely related, and the two promote each other, forming a vicious circle . The symptoms of knee osteoarthritis can be relieved by treating osteoporosis. However, there is no report about denosumab in the treatment of knee osteoarthritis. Therefore, this project plans to use a prospective, single center randomized controlled trial to study the clinical efficacy of denosumab in the treatment of patients with knee osteoarthritis and osteoporosis.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Wuhan Union Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

subject recruitment

  • the research object comes from outpatient patients
  • recruitment advertisement for publicity

Description

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 .

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
desumumab1
60mg, single injection.
Drug: Denosumab
Desumumab, 60mg single injection
desumumab2
60mg, single injection.
Drug: Denosumab
Desumumab, 60mg single injection
desumumab 3
60mg, single injection.
Drug: Denosumab
Desumumab, 60mg single injection
desumumab4
60mg, single injection.
Drug: Denosumab
Desumumab, 60mg single injection
desumumab5
60mg, single injection.
Drug: Denosumab
Desumumab, 60mg single injection
desumumab 6
60mg, single injection.
Drug: Denosumab
Desumumab, 60mg single injection
desumumab7
60mg, single injection.
Drug: Denosumab
Desumumab, 60mg single injection
desumumab 8
60mg, single injection.
Drug: Denosumab
Desumumab, 60mg single injection
desumumab 9
60mg, single injection.
Drug: Denosumab
Desumumab, 60mg single injection
desumumab 10
60mg, single injection.
Drug: Denosumab
Desumumab, 60mg single injection
desumumab 11
60mg, single injection.
Drug: Denosumab
Desumumab, 60mg single injection
desumumab 12
60mg, single injection.
Drug: Denosumab
Desumumab, 60mg single injection
desumumab 13
60mg, single injection.
Drug: Denosumab
Desumumab, 60mg single injection
desumumab 14
60mg, single injection.
Drug: Denosumab
Desumumab, 60mg single injection
desumumab 15
60mg, single injection.
Drug: Denosumab
Desumumab, 60mg single injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee pain relief
Time Frame: 1,3,6 months
OKS function of knee joint at 1,3 and 6 months, VAS pain score at 1,3 and 6 months;
1,3,6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee pain relief and incidence of adverse reactions
Time Frame: 1,3,6 months
Knee joint WOMAC score（maximum：250 ，minimum：0） at 1,3 and 6 months；incidence of adverse reactions;EQ-5D quality of life score at 1,3 and 6 months；
1,3,6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuhan Union Hospital, China

Investigators

  • Principal Investigator: Tian Hongtao, Doctorate, Wuhan Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

August 5, 2023

First Submitted That Met QC Criteria

April 4, 2024

First Posted (Actual)

April 10, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 4, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202286

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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