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99Tc-MDP Treatment for Knee Osteoarthritis

NCT ID: NCT02993029

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2025-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Treatment Outcome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

99Tc-MDP

Intervention Type 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.

celecoxib

celecoxib capsule 200mg qd by mouth.

Group Type ACTIVE_COMPARATOR

Celecoxib

Intervention Type DRUG

Celecoxib capsule 200mg qd by mouth.

Interventions

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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.

Intervention Type DRUG

Celecoxib

Celecoxib capsule 200mg qd by mouth.

Intervention Type DRUG

Other Intervention Names

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Yunke Xile Bao

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Chao Ma

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhongwei Lv, MD

Role: PRINCIPAL_INVESTIGATOR

The 10th Hospital, Tongji University

Locations

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

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chao Ma, MD

Role: CONTACT

[email protected]
+86-021-25078593

Facility Contacts

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Chao Ma, MD

Role: primary

[email protected]
+86021-66302075

Haidong Cai, MD

Role: backup

[email protected]
+86021-66302075

Yanlei Huo, BA

Role: backup

Jianhao Huo, BA

Role: backup

Danyang Wang, BA

Role: backup

Jing Xu, MD

Role: backup

Kejia Gao, BA

Role: backup

Haidong Cai, MD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 1417117 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21666238 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22563589 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10343536 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17662626 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27327630 (View on PubMed)

Other Identifiers

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osteoarthritis

Identifier Type: -

Identifier Source: org_study_id