Status:
UNKNOWN
A Study of Alendronate Sodium Vitamin D3 Tablets on Knee Osteoarthritis
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
CSPC Ouyi Pharmaceutical Co., Ltd.
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
50-75 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the effect of alendronate sodium vitamin D3 tablets compared with placebo on the improvement of joint structure and joint pain in participants with knee osteoa...
Detailed Description
This is a multi-center, randomized, double-blind, placebo-controlled study This study is planned to commence after obtaining Ethics Committee approval. participants will be randomised to a one-year co...
Eligibility Criteria
Inclusion
- Patients with significant knee pain (pain score≥40mm on the 100mmVAS scale);
- Male or female patients, between 50-75 years old;
- MRI suggests bone marrow edema-like lesions;
- Knee osteoarthritis (in accordance with the diagnostic criteria of American College of Rheumatology (ACR) and Chinese Orthopaedic Association);
- Kellgren-Lawrence gradingⅠorⅡin X-ray;
Exclusion
- Other forms of active arthritis (such as rheumatoid arthritis or other inflammatory arthritis);
- Taken non-steroidal anti-inflammatory drugs and central analgesics (such as opioids) within two weeks；
- Liver function ALT or AST is 1.5 times the upper limit of normal； creatinine clearance \<35ml/min；
- Pregnancy or suckling;
- Serious heart disease, endocrine, digestive, mental, nervous system diseases or cancer;
- Active ulcers and a history of upper gastrointestinal bleeding;
- Esophageal motility disorders, such as esophageal tardiness or stenosis;
- Renal dysfunction or osteomalacia;
- Tobacco addiction (mean 10 cigarettes per day or more) or/and alcohol addiction (mean 50ml per day or more);
- Fresh fracture in the last six months;
- Serious illnesses and life expectancy\<2 years;
- Allergic to study drugs;
- Used any study drug or device within 30 days before randomization or within the drug half-life (whichever is longer);
- Failure to take medication as required;
- Replacement surgery in the near future;
- Contraindications to MRI scans (e.g. implanted pacemakers, metal sutures, shrapnel or iron filings in the eyes, claustrophobia, knees too large to use coils);
- Sensitive to or unsuitable for X-ray exposure (e.g. aplastic anemia, etc);
- Poor dental health or dental surgery in the near future.
Key Trial Info
Start Date :
July 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04739592
Start Date
July 7 2021
End Date
July 1 2024
Last Update
April 22 2022
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking Union Medical College Hospital
Beijing, China
2
The Third Affiliated Hospital of Southern Medical University
Guangzhou, China
3
Zhongshan Hospital
Shanghai, China