Clinical Study of Desuzumab in the Treatment of Knee Osteoarthritis

NCT ID: NCT06357741

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2025-12-31

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 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.

Conditions

Knee Osteoarthritis

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

desumumab1

60mg, single injection.

Denosumab

Intervention Type: DRUG

Desumumab, 60mg single injection

desumumab2

60mg, single injection.

Denosumab

Intervention Type: DRUG

Desumumab, 60mg single injection

desumumab 3

60mg, single injection.

Denosumab

Intervention Type: DRUG

Desumumab, 60mg single injection

desumumab4

60mg, single injection.

Denosumab

Intervention Type: DRUG

Desumumab, 60mg single injection

desumumab5

60mg, single injection.

Denosumab

Intervention Type: DRUG

Desumumab, 60mg single injection

desumumab 6

60mg, single injection.

Denosumab

Intervention Type: DRUG

Desumumab, 60mg single injection

desumumab7

60mg, single injection.

Denosumab

Intervention Type: DRUG

Desumumab, 60mg single injection

desumumab 8

60mg, single injection.

Denosumab

Intervention Type: DRUG

Desumumab, 60mg single injection

desumumab 9

60mg, single injection.

Denosumab

Intervention Type: DRUG

Desumumab, 60mg single injection

desumumab 10

60mg, single injection.

Denosumab

Intervention Type: DRUG

Desumumab, 60mg single injection

desumumab 11

60mg, single injection.

Denosumab

Intervention Type: DRUG

Desumumab, 60mg single injection

desumumab 12

60mg, single injection.

Denosumab

Intervention Type: DRUG

Desumumab, 60mg single injection

desumumab 13

60mg, single injection.

Denosumab

Intervention Type: DRUG

Desumumab, 60mg single injection

desumumab 14

60mg, single injection.

Denosumab

Intervention Type: DRUG

Desumumab, 60mg single injection

desumumab 15

60mg, single injection.

Denosumab

Intervention Type: DRUG

Desumumab, 60mg single injection

Interventions

Denosumab

Desumumab, 60mg single injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Tian Hongtao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tian Hongtao, Doctorate

Role: PRINCIPAL_INVESTIGATOR

Wuhan Union Medical College Hospital

Locations

Wuhan Union Hospital

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Tian Hongtao, Doctorate

Role: CONTACT

tianhongtao@vip.163.com

18627171618

Facility Contacts

Hongtao Tian, doctor

Role: primary

tianhongtao@vip.163.com

18627171618

References

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.

Reference Type: BACKGROUND

PMID: 29055350 (View on PubMed)

Ernest 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.

Reference Type: BACKGROUND

PMID: 30115587 (View on PubMed)

Zhou 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.

Reference Type: BACKGROUND

PMID: 28510268 (View on PubMed)

Sobacchi 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.

Reference Type: RESULT

PMID: 17632511 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

202286

Identifier Type: -

Identifier Source: org_study_id