Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06357741
Status:
COMPLETED
Last Update Posted:
2024-04-10
First Post:
2023-08-05
Brief Title:
Clinical Study of Desuzumab in the Treatment of Knee Osteoarthritis
Sponsor:
Wuhan Union Hospital China
Organization:
Wuhan Union Hospital China
Study Overview
Official Title:
Clinical Study of Desuzumab in the Treatment of Knee Osteoarthritis
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CSODITTOKO
Brief Summary:
As an activator of inhibiting nuclear factor kB receptor denosumab affects osteoclast differentiation and development by inhibiting OPGRANKL-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 worlds elderly population will reach 202 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None