NCT06357741

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2023

Completed
8 months until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 9, 2025

Status Verified

March 1, 2025

Enrollment Period

4.3 years

First QC Date

August 5, 2023

Last Update Submit

April 4, 2025

Conditions

Knee Osteoarthritis

Keywords

denosumabknee osteoarthritiscurative effect

Outcome Measures

Primary Outcomes (1)

  • Knee pain relief

    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 Outcomes (1)

  • Knee pain relief and incidence of adverse reactions

    1,3,6 months

Study Arms (15)

desumumab1

60mg, single injection.

Drug: Denosumab

desumumab2

60mg, single injection.

Drug: Denosumab

desumumab 3

60mg, single injection.

Drug: Denosumab

desumumab4

60mg, single injection.

Drug: Denosumab

desumumab5

60mg, single injection.

Drug: Denosumab

desumumab 6

60mg, single injection.

Drug: Denosumab

desumumab7

60mg, single injection.

Drug: Denosumab

desumumab 8

60mg, single injection.

Drug: Denosumab

desumumab 9

60mg, single injection.

Drug: Denosumab

desumumab 10

60mg, single injection.

Drug: Denosumab

desumumab 11

60mg, single injection.

Drug: Denosumab

desumumab 12

60mg, single injection.

Drug: Denosumab

desumumab 13

60mg, single injection.

Drug: Denosumab

desumumab 14

60mg, single injection.

Drug: Denosumab

desumumab 15

60mg, single injection.

Drug: Denosumab

Interventions

DenosumabDRUG

Desumumab, 60mg single injection

desumumab 10desumumab 11desumumab 12desumumab 13desumumab 14desumumab 15desumumab 3desumumab 6desumumab 8desumumab 9desumumab1desumumab2desumumab4desumumab5desumumab7

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

subject recruitment * the research object comes from outpatient patients * recruitment advertisement for publicity

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan Union Hospital

Wuhan, Hubei, 430000, China

RECRUITING

Related Publications (4)

  • 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.

    PMID: 29055350BACKGROUND

  • 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.

    PMID: 30115587BACKGROUND

  • 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.

    PMID: 28510268BACKGROUND

  • 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.

    PMID: 17632511RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Some patients receiving denosumab injections requested to withdraw from the trial to undergo knee replacement, during which synovial tissue samples were collected for H\&E, IHC staining, and Western blot. Knee replacement inherently requires partial synovectomy to prevent postoperative joint crepitus and alleviate inflammatory pain. The resected pathological tissues during knee replacement-including synovium and cartilage-are routinely sent for pathological examination to exclude neoplasms or infections, confirm diagnoses, and guide postoperative management. Studies suggest that denosumab may effectively reduce periprosthetic fracture risk. Thus, even after trial withdrawal, patients can benefit from its osteoporotic therapeutic effects in preventing post-arthroplasty complications such as prosthetic loosening and periprosthetic fractures. In addition, we could also check whether there are some protective effects by denosumab on molecular level.

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Denosumab

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Tian Hongtao, Doctorate

    Wuhan Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tian Hongtao, Doctorate

CONTACT

18627171618tianhongtao@vip.163.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 5, 2023

First Posted

April 10, 2024

Study Start

August 1, 2021

Primary Completion

December 1, 2025

Study Completion

December 31, 2025

Last Updated

April 9, 2025

Record last verified: 2025-03

Locations

CN(1)