Treatment OutcomeNCT02993029
99Tc-MDP Treatment for Knee Osteoarthritis
A study testing 99Tc-MDP and Celecoxib in people with Treatment Outcome, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Treatment Outcome
- What is being tested?
- 99Tc-MDP and Celecoxib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Knee joint replacement;
- Inflammatory arthritis or joint infection of knee;
- Nervous joint disease;
- Fracture of joint;
- Gout arthritis of the knee;
- Traumatic arthritis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Nuclear Medicine, Tenth People's Hospital of Tongji University
Shanghai, Shanghai Municipality, 200072
Chao Ma, MD, +86021-66302075, mc_7419@hotmail.com
Haidong Cai, MD, +86021-66302075, caihdong@163.com
About this study
Official title: 99Tc-MDP Versus Celecoxib Treatment in Patients With 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.
Read the 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.
- Conditions
- Treatment Outcome
- Being tested
- 99Tc-MDP, Celecoxib
- Keywords
- 99Tc-MDP, osteoarthritis, celecoxib
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
99Tc-MDPDrug
Also called Yunke
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.
CelecoxibDrug
Also called Xile Bao
Celecoxib capsule 200mg qd by mouth.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: 99Tc-MDP |
| celecoxib | Active comparator | celecoxib capsule 200mg qd by mouth. Receives: Drug: Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, and 6, 12 months after treatment.
Secondary outcomes (4)
health-related quality of life
change of health-related quality of life (mean and standard deviation) by SF-36
Measured: baseline, and 6, 12 months after treatment.
staging of knee osteoarthritisby
number of participants who have change of knee osteoarthritis staging by X-ray or CT
Measured: baseline and 12 months after treatment.
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
Measured: baseline and 12 months after treatment.
adverse events
adverse events that are related to treatment
Measured: 3, 6, 12 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study start1 Sep 2017
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Treatment OutcomeStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chao Ma, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Zhongwei Lv, MD, Principal investigator, The 10th Hospital, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993029
- Sponsor's protocol ID
- osteoarthritis
- Status last verified
- Apr 2026
- First submitted
- 8 Dec 2016
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21666238Hochberg 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.
PubMed 22563589Boegard 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.
PubMed 10343536Kim 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.
PubMed 17662626Liu 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.
PubMed 27327630McCrae 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.
PubMed 1417117
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 99Tc-MDP Versus Celecoxib Treatment in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02993029
- Acronym / sponsor ID
- osteoarthritis
- Conditions
- Treatment Outcome
- Keywords
- 99Tc-MDP, osteoarthritis, celecoxib
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 14 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 99Tc-MDP | Experimental | Drug: 99Tc-MDP99Tc-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 | Active comparator | Drug: Celecoxibcelecoxib capsule 200mg qd by mouth. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- Knee joint replacement;
- Inflammatory arthritis or joint infection of knee;
- Nervous joint disease;
- Fracture of joint;
- Gout arthritis of the knee;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 99Tc-MDPAlso: Yunke99Tc-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. | Drug | 99Tc-MDP |
| CelecoxibAlso: Xile BaoCelecoxib capsule 200mg qd by mouth. | Drug | celecoxib |
Primary outcome
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
4 secondary outcomes
health-related quality of life
Time frame: baseline, and 6, 12 months after treatment.
staging of knee osteoarthritisby
Time frame: baseline and 12 months after treatment.
standard uptake value of knee
Time frame: baseline and 12 months after treatment.
adverse events
Time frame: 3, 6, 12 months after treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Background: PubMed 21666238Lai 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.
- Background: PubMed 22563589Hochberg 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.
- Background: PubMed 10343536Boegard 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.
- Background: PubMed 17662626Kim 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.
- Background: PubMed 27327630Liu 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 publication: PubMed 1417117McCrae 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.
- Individual participant dataSharing planned: No
Related trials for Treatment Outcome
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhongwei Lv, MD principal investigator
The 10th Hospital, Tongji University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 99Tc-MDP and Celecoxib in people with Treatment Outcome, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chao Ma, MD (+86-021-25078593, mc_7419@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain, stiffness and joint function of knee (time frame: baseline, and 6, 12 months after treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02993029, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.