Knee OsteoarthritisCSODITTOKONCT06357741
Clinical Study of Desuzumab in the Treatment of Knee Osteoarthritis
An observational study of Knee Osteoarthritis, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Denosumab
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: subject recruitment * the research object comes from outpatient patients * recruitment advertisement for publicity
Who may be able to join
- 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 .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Wuhan Union Hospital
Wuhan, Hubei, 430000
Hongtao Tian, doctor, 18627171618, tianhongtao@vip.163.com
About this study
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Denosumab
- Keywords
- denosumab, knee osteoarthritis, curative effect
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DenosumabDrug
Desumumab, 60mg single injection
| Study group | Role | What they receive |
|---|---|---|
| desumumab1 | 60mg, single injection. Receives: Drug: Denosumab | |
| desumumab2 | 60mg, single injection. Receives: Drug: Denosumab | |
| desumumab 3 | 60mg, single injection. Receives: Drug: Denosumab | |
| desumumab4 | 60mg, single injection. Receives: Drug: Denosumab | |
| desumumab5 | 60mg, single injection. Receives: Drug: Denosumab | |
| desumumab 6 | 60mg, single injection. Receives: Drug: Denosumab | |
| desumumab7 | 60mg, single injection. Receives: Drug: Denosumab | |
| desumumab 8 | 60mg, single injection. Receives: Drug: Denosumab | |
| desumumab 9 | 60mg, single injection. Receives: Drug: Denosumab | |
| desumumab 10 | 60mg, single injection. Receives: Drug: Denosumab | |
| desumumab 11 | 60mg, single injection. Receives: Drug: Denosumab | |
| desumumab 12 | 60mg, single injection. Receives: Drug: Denosumab | |
| desumumab 13 | 60mg, single injection. Receives: Drug: Denosumab | |
| desumumab 14 | 60mg, single injection. Receives: Drug: Denosumab | |
| desumumab 15 | 60mg, single injection. Receives: Drug: Denosumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee pain relief
OKS function of knee joint at 1,3 and 6 months, VAS pain score at 1,3 and 6 months;
Measured: 1,3,6 months
Secondary outcomes (1)
Knee pain relief and incidence of adverse reactions
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；
Measured: 1,3,6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start1 Aug 2021
- Primary completion1 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tian Hongtao, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Tian Hongtao, Doctorate, Principal investigator, Wuhan Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357741
- Sponsor's protocol ID
- 202286
- Acronym
- CSODITTOKO
- Status last verified
- Mar 2025
- First submitted
- 5 Aug 2023
- Last updated
- 9 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
He XF, Zhang L, Zhang CH, Zhao CR, Li H, Zhang LF, Tian GF, Guo MF, Dai Z, Sui FG. Berberine alleviates oxidative stress in rats with osteoporosis through receptor activator of NF-kB/receptor activator of NF-kB ligand/osteoprotegerin (RANK/RANKL/OPG) pathway. Bosn J Basic Med Sci. 2017 Nov 20;17(4):295-301. doi: 10.17305/bjbms.2017.2596.
PubMed 29055350Ernest TL, Kondrashov PE. The role of excessive body weight and meniscal instability in the progression of osteoarthritis in a rat model. Knee. 2018 Dec;25(6):1151-1156. doi: 10.1016/j.knee.2018.07.009. Epub 2018 Aug 13.
PubMed 30115587Zhou J, Liao Y, Zeng Y, Xie H, Fu C, Li N. Effect of intervention initiation timing of pulsed electromagnetic field on ovariectomy-induced osteoporosis in rats. Bioelectromagnetics. 2017 Sep;38(6):456-465. doi: 10.1002/bem.22059. Epub 2017 May 16.
PubMed 28510268Sobacchi C, Frattini A, Guerrini MM, Abinun M, Pangrazio A, Susani L, Bredius R, Mancini G, Cant A, Bishop N, Grabowski P, Del Fattore A, Messina C, Errigo G, Coxon FP, Scott DI, Teti A, Rogers MJ, Vezzoni P, Villa A, Helfrich MH. Osteoclast-poor human osteopetrosis due to mutations in the gene encoding RANKL. Nat Genet. 2007 Aug;39(8):960-2. doi: 10.1038/ng2076. Epub 2007 Jul 15.
PubMed 17632511
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Desuzumab in the Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06357741
- Acronym / sponsor ID
- CSODITTOKO / 202286
- Conditions
- Knee Osteoarthritis
- Keywords
- denosumab, knee osteoarthritis, curative effect
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 15
| Arm | Type | Receives |
|---|---|---|
| desumumab1 | – | Drug: Denosumab60mg, single injection. |
| desumumab2 | – | Drug: Denosumab60mg, single injection. |
| desumumab 3 | – | Drug: Denosumab60mg, single injection. |
| desumumab4 | – | Drug: Denosumab60mg, single injection. |
| desumumab5 | – | Drug: Denosumab60mg, single injection. |
| desumumab 6 | – | Drug: Denosumab60mg, single injection. |
| desumumab7 | – | Drug: Denosumab60mg, single injection. |
| desumumab 8 | – | Drug: Denosumab60mg, single injection. |
| desumumab 9 | – | Drug: Denosumab60mg, single injection. |
| desumumab 10 | – | Drug: Denosumab60mg, single injection. |
| desumumab 11 | – | Drug: Denosumab60mg, single injection. |
| desumumab 12 | – | Drug: Denosumab60mg, single injection. |
| desumumab 13 | – | Drug: Denosumab60mg, single injection. |
| desumumab 14 | – | Drug: Denosumab60mg, single injection. |
| desumumab 15 | – | Drug: Denosumab60mg, single injection. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- subject recruitment * the research object comes from outpatient patients * recruitment advertisement for publicity
Key inclusion criteria (8 listed)
- 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 .
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DenosumabDesumumab, 60mg single injection | Drug | desumumab 10, desumumab 11, desumumab 12, desumumab 13, desumumab 14, desumumab 15, desumumab 3, desumumab 6, desumumab 8, desumumab 9, desumumab1, desumumab2, desumumab4, desumumab5, desumumab7 |
Primary outcome
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 secondary outcome
Knee pain relief and incidence of adverse reactions
Time frame: 1,3,6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Background: PubMed 29055350He XF, Zhang L, Zhang CH, Zhao CR, Li H, Zhang LF, Tian GF, Guo MF, Dai Z, Sui FG. Berberine alleviates oxidative stress in rats with osteoporosis through receptor activator of NF-kB/receptor activator of NF-kB ligand/osteoprotegerin (RANK/RANKL/OPG) pathway. Bosn J Basic Med Sci. 2017 Nov 20;17(4):295-301. doi: 10.17305/bjbms.2017.2596.
- Background: PubMed 30115587Ernest TL, Kondrashov PE. The role of excessive body weight and meniscal instability in the progression of osteoarthritis in a rat model. Knee. 2018 Dec;25(6):1151-1156. doi: 10.1016/j.knee.2018.07.009. Epub 2018 Aug 13.
- Background: PubMed 28510268Zhou J, Liao Y, Zeng Y, Xie H, Fu C, Li N. Effect of intervention initiation timing of pulsed electromagnetic field on ovariectomy-induced osteoporosis in rats. Bioelectromagnetics. 2017 Sep;38(6):456-465. doi: 10.1002/bem.22059. Epub 2017 May 16.
- Results publication: PubMed 17632511Sobacchi C, Frattini A, Guerrini MM, Abinun M, Pangrazio A, Susani L, Bredius R, Mancini G, Cant A, Bishop N, Grabowski P, Del Fattore A, Messina C, Errigo G, Coxon FP, Scott DI, Teti A, Rogers MJ, Vezzoni P, Villa A, Helfrich MH. Osteoclast-poor human osteopetrosis due to mutations in the gene encoding RANKL. Nat Genet. 2007 Aug;39(8):960-2. doi: 10.1038/ng2076. Epub 2007 Jul 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tian Hongtao, Doctorate principal investigator
Wuhan Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tian Hongtao, Doctorate (18627171618, tianhongtao@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee pain relief (time frame: 1,3,6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06357741, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.