99Tc-MDP Treatment for Knee Osteoarthritis

April 22, 2026 updated by: Chao Ma, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

99Tc-MDP Versus Celecoxib Treatment in Patients With Knee Osteoarthritis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The prevalence of osteoarthritis of the knee (OA) is increasing worldwide and this burden will continue to increase owing to aging of the general population 99Tc-MDP is effective for rheumatoid arthritis. Consequent to an increase in incidence is the rise in the number of patients with knee OA who are prone to further deterioration of the knee. It therefore is important to better understand, control, and attempt to prevent further progression of disease in patients with knee OA. Limitations in walking, stair climbing, and squatting are common patient complaints that greatly interfere with activities of daily living and recreation. Currently there is no definite consensus on the standardized management of OA. Oral analgesic and anti-inflammatory agents are perhaps the most commonly prescribed treatments to alleviate knee OA symptoms. The failure of nonsurgical therapies to modify quality of life in knee OA patients is not surprising given their inability to alleviate physical manifestations of OA. Surgical knee OA interventions generally result in good to excellent patient outcomes. However, there are significant barriers to considering surgery, which limits clinical utility.

99Tc-MDP is actually the decay product of 99mTc-MDP (99mTc-methylene diphosphonate, a US Food and Drug Administration-approved radioactive agent widely used for bone scintigraphy). 99Tc-MDP (Chengdu Yunke Pharmaceutical, Sichuan, China) is a kind of anti-inflammatory drug patented in China (patent no. ZL94113006.1). It was approved for production by the State Food and Drug Administration of China in October 1997. 99Tc-MDP has been demonstrated to be safe and effective in the clinical treatment of immune diseases, such as rheumatoid arthritis (RA), ankylosing spondylitis (AS) and certain bone diseases, such as skeletal metastases from cancer in China. 99Tc-MDP also showed clinical effect on knee OA in our practice. Therefore, the investigators try to investigate the effects of 99Tc-MDP treatment in patients with osteoarthritis of knee as compared with celecoxib.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200072
        • Recruiting
        • Department of Nuclear Medicine, Tenth People's Hospital of Tongji University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Yanlei Huo, BA
        • Principal Investigator:
          • Jianhao Huo, BA
        • Sub-Investigator:
          • Danyang Wang, BA
        • Sub-Investigator:
          • Jing Xu, MD
        • Principal Investigator:
          • Kejia Gao, BA
        • Sub-Investigator:
          • Haidong Cai, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Participants with painful osteoarthritis;
  2. The standard uptake value (SUV) of OA related knee greater than 10 on 18F- sodium fluoride bone scan;
  3. Participants voluntarily participate in the trial, and signed the informed consent.

Exclusion Criteria:

  1. Knee joint replacement;
  2. Inflammatory arthritis or joint infection of knee;
  3. Nervous joint disease;
  4. Fracture of joint;
  5. Gout arthritis of the knee;
  6. Traumatic arthritis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 99Tc-MDP
99Tc-MDP group: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.
Drug: 99Tc-MDP
99Tc-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.
Other Names:
  • Yunke
Active Comparator: celecoxib
celecoxib capsule 200mg qd by mouth.
Drug: Celecoxib
Celecoxib capsule 200mg qd by mouth.
Other Names:
  • Xile Bao

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain, stiffness and joint function of knee
Time Frame: baseline, and 6, 12 months after treatment.
change of the pain, stiffness and joint function of knee (mean and standard deviation) by Western Ontario and McMaster Universities (WOMAC)Osteoarthritis Index
baseline, and 6, 12 months after treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
health-related quality of life
Time Frame: baseline, and 6, 12 months after treatment.
change of health-related quality of life (mean and standard deviation) by SF-36
baseline, and 6, 12 months after treatment.
staging of knee osteoarthritisby
Time Frame: baseline and 12 months after treatment.
number of participants who have change of knee osteoarthritis staging by X-ray or CT
baseline and 12 months after treatment.
standard uptake value of knee
Time Frame: baseline and 12 months after treatment.
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
baseline and 12 months after treatment.
adverse events
Time Frame: 3, 6, 12 months after treatment.
adverse events that are related to treatment
3, 6, 12 months after treatment.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone mineral density
Time Frame: baseline and 12 months after treatment.
The changes of bone mineral density(mean and standard deviation) in lumbar and hip by a dual energy x-ray absorotiometrv
baseline and 12 months after treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Zhongwei Lv, MD, The 10th Hospital, Tongji University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

December 8, 2016

First Submitted That Met QC Criteria

December 12, 2016

First Posted (Estimated)

December 14, 2016

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • osteoarthritis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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