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NCT Number: NCT02993029

99Tc-MDP Treatment for 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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nuclear Medicine, Tenth People's Hospital of Tongji University

Shanghai, Shanghai Municipality, 200072, China

Location status: Recruiting

Location contact

Chao Ma, MD

CONTACT

[email protected]

+86021-66302075

Danyang Wang, BA

SUB_INVESTIGATOR

Haidong Cai, MD

CONTACT

[email protected]

+86021-66302075

Haidong Cai, MD

SUB_INVESTIGATOR

Jianhao Huo, BA

PRINCIPAL_INVESTIGATOR

Jing Xu, MD

SUB_INVESTIGATOR

Kejia Gao, BA

PRINCIPAL_INVESTIGATOR

Yanlei Huo, BA

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Knee joint replacement;
  • Inflammatory arthritis or joint infection of knee;
  • Nervous joint disease;
  • Fracture of joint;
  • Gout arthritis of the knee;
  • Traumatic arthritis.

Treatment and study plan

99Tc-MDP

Drug

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

Celecoxib

Drug

Celecoxib capsule 200mg qd by mouth.

Other names: Xile Bao

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. adverse events

    Time frame: 3, 6, 12 months after treatment.

    adverse events that are related to treatment

Other outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Chao Ma, MD

CONTACT

[email protected]

+86-021-25078593

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Dec 14, 2016
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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