99Tc-MDP Treatment for Knee Osteoarthritis

Treatment Outcome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02993029
• Other study ID #: osteoarthritis
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: December 30, 2024

Study information

• Verified date: November 2023
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Chao Ma, MD
• Phone: +86-021-25078593
• Email: mc_7419[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Treatment Outcome

Intervention

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.
• Celecoxib
Celecoxib capsule 200mg qd by mouth.

Locations

Country	Name	City	State
China	Department of Nuclear Medicine, Tenth People's Hospital of Tongji University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (6)

Boegard T, Rudling O, Dahlstrom J, Dirksen H, Petersson IF, Jonsson K. Bone scintigraphy in chronic knee pain: comparison with magnetic resonance imaging. Ann Rheum Dis. 1999 Jan;58(1):20-6. doi: 10.1136/ard.58.1.20. — View Citation

Hochberg MC, Altman RD, April KT, Benkhalti M, Guyatt G, McGowan J, Towheed T, Welch V, Wells G, Tugwell P; American College of Rheumatology. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken). 2012 Apr;64(4):465-74. doi: 10.1002/acr.21596. — View Citation

Kim HR, So Y, Moon SG, Lee IS, Lee SH. Clinical value of (99m)Tc-methylene diphosphonate (MDP) bone single photon emission computed tomography (SPECT) in patients with knee osteoarthritis. Osteoarthritis Cartilage. 2008 Feb;16(2):212-8. doi: 10.1016/j.joca.2007.05.025. Epub 2007 Jul 27. — View Citation

Lai K, Xu L, Jin C, Wu K, Tian Z, Huang C, Zhong X, Ye H. Technetium-99 conjugated with methylene diphosphonate (99Tc-MDP) inhibits experimental choroidal neovascularization in vivo and VEGF-induced cell migration and tube formation in vitro. Invest Ophthalmol Vis Sci. 2011 Jul 29;52(8):5702-12. doi: 10.1167/iovs.10-6370. — View Citation

Liu H, Guo H, Guo S, Wang J, Ye Y, Ma C. Novel treatment of 99Tc-MDP improves clinical and radiographic results for patients with osteochondral lesions of the talus. Q J Nucl Med Mol Imaging. 2019 Jun;63(2):199-206. doi: 10.23736/S1824-4785.16.02872-7. Epub 2016 Jun 21. — View Citation

McCrae F, Shouls J, Dieppe P, Watt I. Scintigraphic assessment of osteoarthritis of the knee joint. Ann Rheum Dis. 1992 Aug;51(8):938-42. doi: 10.1136/ard.51.8.938. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	bone mineral density	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.
Primary	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	baseline, and 6, 12 months after treatment.
Secondary	health-related quality of life	change of health-related quality of life (mean and standard deviation) by SF-36	baseline, and 6, 12 months after treatment.
Secondary	staging of knee osteoarthritisby	number of participants who have change of knee osteoarthritis staging by X-ray or CT	baseline and 12 months after treatment.
Secondary	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	baseline and 12 months after treatment.
Secondary	adverse events	adverse events that are related to treatment	3, 6, 12 months after treatment.