99Tc-MDP Treatment for Knee Osteoarthritis

NCT02993029 | Recruiting DMC

• 1 other identifier: osteoarthritis
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Treatment Outcome

Keywords

99Tc-MDP; osteoarthritis; celecoxib

Outcome Measures

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

  baseline, and 6, 12 months after treatment.

Secondary Outcomes (4)

• health-related quality of life

  baseline, and 6, 12 months after treatment.

• staging of knee osteoarthritisby

  baseline and 12 months after treatment.

• standard uptake value of knee

  baseline and 12 months after treatment.

• adverse events

  3, 6, 12 months after treatment.

Other Outcomes (1)

• bone mineral density

  baseline and 12 months after treatment.

Study Arms (2)

99Tc-MDP

EXPERIMENTAL

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

celecoxib

ACTIVE COMPARATOR

celecoxib capsule 200mg qd by mouth.

Drug: Celecoxib

Interventions

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.

Also known as: Yunke

99Tc-MDP

Celecoxib DRUG

Celecoxib capsule 200mg qd by mouth.

Also known as: Xile Bao

celecoxib

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200072, China

RECRUITING

Related Publications (6)

• 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.

  PMID: 21666238 BACKGROUND

• 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.

  PMID: 22563589 BACKGROUND

• 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.

  PMID: 10343536 BACKGROUND

• 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.

  PMID: 17662626 BACKGROUND

• 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.

  PMID: 27327630 BACKGROUND

• 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.

  PMID: 1417117 RESULT

MeSH Terms

Conditions

Osteoarthritis

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Zhongwei Lv, MD

  The 10th Hospital, Tongji University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao Ma, MD

CONTACT

+86-021-25078593; mc_7419@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: December 14, 2016
• Study Start: September 1, 2017
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)