99Tc-MDP Treatment for Knee Osteoarthritis
ConditionTreatment Outcome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine
About this trial
Osteoarthritis (OA) of knee is the most common form of arthritis in the world1e, and it has received growing attention in the society because of the increase of old age population, disabled people, and medical expenses from this disease. 99Tc-MDP is effective for rheumatoid arthritis. Therefore, the investigators try to investigate the effects of 99Tc-MDP treatment in patients with osteoarthritis of knee as compared with celecoxib.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants with painful osteoarthritis;
The standard uptake value (SUV) of OA related knee greater than 10 on 18F- sodium fluoride bone scan;
Participants voluntarily participate in the trial, and signed the informed consent.
Disqualifiers
Knee joint replacement;
Inflammatory arthritis or joint infection of knee;
Nervous joint disease;
Fracture of joint;
Trial design
Design model
Parallel
Treatments tested in this trial
99Tc-MDP
Drug99Tc-MDP 15mg in 100ml normal saline intravenously dripped every twice a week for 5 weeks, every 1weeks for 10 weeks, every 2weeks for 10 weeks, every 1 month for 6 months.
Celecoxib
DrugCelecoxib capsule 200mg qd by mouth.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: 99Tc-MDPExperimental treatment 1 intervention
Group B: celecoxibActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
pain, stiffness and joint function of knee
change of the pain, stiffness and joint function of knee (mean and standard deviation) by Western Ontario and McMaster Universities (WOMAC)Osteoarthritis Index
Time frame
baseline, and 6, 12 months after treatment.Secondary outcomes
1
health-related quality of life
change of health-related quality of life (mean and standard deviation) by SF-36
Time frame
baseline, and 6, 12 months after treatment.2
staging of knee osteoarthritisby
number of participants who have change of knee osteoarthritis staging by X-ray or CT
Time frame
baseline and 12 months after treatment.3
standard uptake value of knee
change of standard uptake value (SUV,mean and standard deviation) of knee on 18F- sodium fluoride or 99Tc-MDP bone scan and change of cystic area on according CT
Time frame
baseline and 12 months after treatment.4
adverse events
adverse events that are related to treatment
Time frame
3, 6, 12 months after treatment.Other outcomes
1
bone mineral density
The changes of bone mineral density(mean and standard deviation) in lumbar and hip by a dual energy x-ray absorotiometrv
Time frame
baseline and 12 months after treatment.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov