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99Tc-MDP Treatment for Knee Osteoarthritis

Primary Purpose

Treatment Outcome

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
99Tc-MDP
Celecoxib
Sponsored by
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment Outcome focused on measuring 99Tc-MDP, osteoarthritis, celecoxib

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Nuclear Medicine, Tenth People's Hospital of Tongji UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

99Tc-MDP

celecoxib

Arm Description

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.

celecoxib capsule 200mg qd by mouth.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

health-related quality of life
change of health-related quality of life (mean and standard deviation) by SF-36
staging of knee osteoarthritisby
number of participants who have change of knee osteoarthritis staging by X-ray or CT
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
adverse events
adverse events that are related to treatment

Full Information

First Posted
December 8, 2016
Last Updated
October 24, 2022
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02993029
Brief Title
99Tc-MDP Treatment for Knee Osteoarthritis
Official Title
99Tc-MDP Versus Celecoxib Treatment in Patients With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Outcome
Keywords
99Tc-MDP, osteoarthritis, celecoxib

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
99Tc-MDP
Arm Type
Experimental
Arm Description
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.
Arm Title
celecoxib
Arm Type
Active Comparator
Arm Description
celecoxib capsule 200mg qd by mouth.
Intervention Type
Drug
Intervention Name(s)
99Tc-MDP
Other Intervention Name(s)
Yunke
Intervention Description
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
Intervention Name(s)
Celecoxib
Other Intervention Name(s)
Xile Bao
Intervention Description
Celecoxib capsule 200mg qd by mouth.
Primary Outcome Measure Information:
Title
pain, stiffness and joint function of knee
Description
change of the pain, stiffness and joint function of knee (mean and standard deviation) by Western Ontario and McMaster Universities (WOMAC)Osteoarthritis Index
Time Frame
baseline, and 6, 12 months after treatment.
Secondary Outcome Measure Information:
Title
health-related quality of life
Description
change of health-related quality of life (mean and standard deviation) by SF-36
Time Frame
baseline, and 6, 12 months after treatment.
Title
staging of knee osteoarthritisby
Description
number of participants who have change of knee osteoarthritis staging by X-ray or CT
Time Frame
baseline and 12 months after treatment.
Title
standard uptake value of knee
Description
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
Time Frame
baseline and 12 months after treatment.
Title
adverse events
Description
adverse events that are related to treatment
Time Frame
3, 6, 12 months after treatment.
Other Pre-specified Outcome Measures:
Title
bone mineral density
Description
The changes of bone mineral density(mean and standard deviation) in lumbar and hip by a dual energy x-ray absorotiometrv
Time Frame
baseline and 12 months after treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chao Ma, MD
Phone
+86-021-25078593
Email
mc_7419@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhongwei Lv, MD
Organizational Affiliation
The 10th Hospital, Tongji University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nuclear Medicine, Tenth People's Hospital of Tongji University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chao Ma, MD
Phone
+86021-66302075
Email
mc_7419@hotmail.com
First Name & Middle Initial & Last Name & Degree
Haidong Cai, MD
Phone
+86021-66302075
Email
caihdong@163.com
First Name & Middle Initial & Last Name & Degree
Yanlei Huo, BA
First Name & Middle Initial & Last Name & Degree
Jianhao Huo, BA
First Name & Middle Initial & Last Name & Degree
Danyang Wang, BA
First Name & Middle Initial & Last Name & Degree
Jing Xu, MD
First Name & Middle Initial & Last Name & Degree
Kejia Gao, BA
First Name & Middle Initial & Last Name & Degree
Haidong Cai, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21666238
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.
Results Reference
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PubMed Identifier
22563589
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.
Results Reference
background
PubMed Identifier
10343536
Citation
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.
Results Reference
background
PubMed Identifier
17662626
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.
Results Reference
background
PubMed Identifier
27327630
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.
Results Reference
background
PubMed Identifier
1417117
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.
Results Reference
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99Tc-MDP Treatment for Knee Osteoarthritis

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