A Study of Alendronate Sodium Vitamin D3 Tablets on Knee Osteoarthritis
NCT ID: NCT04739592
Last Updated: 2022-04-22
Study Results
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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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2021-07-07
2024-07-31
Brief Summary
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Detailed Description
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As the main goal of this exploratory 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 osteoarthritis. The primary outcome measure is WORMS score of knee joint MRI at 6 months and 12 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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alendronate sodium vitamin D3 tablets
participants will receive alendronate sodium vitamin D3 tablets once per week for one year.
alendronate sodium vitamin D3 tablets
once per week for one year
placebo
participants will receive a placebo tablet once per week for one year.
Placebo
once per week for one year
Interventions
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alendronate sodium vitamin D3 tablets
once per week for one year
Placebo
once per week for one year
Eligibility Criteria
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Inclusion Criteria
2. Male or female patients, between 50-75 years old;
3. MRI suggests bone marrow edema-like lesions;
4. Knee osteoarthritis (in accordance with the diagnostic criteria of American College of Rheumatology (ACR) and Chinese Orthopaedic Association);
5. Kellgren-Lawrence gradingⅠorⅡin X-ray;
Exclusion Criteria
2. Taken non-steroidal anti-inflammatory drugs and central analgesics (such as opioids) within two weeks；
3. Liver function ALT or AST is 1.5 times the upper limit of normal； creatinine clearance \<35ml/min；
4. Pregnancy or suckling;
5. Serious heart disease, endocrine, digestive, mental, nervous system diseases or cancer;
6. Active ulcers and a history of upper gastrointestinal bleeding;
7. Esophageal motility disorders, such as esophageal tardiness or stenosis;
8. Renal dysfunction or osteomalacia;
9. Tobacco addiction (mean 10 cigarettes per day or more) or/and alcohol addiction (mean 50ml per day or more);
10. Fresh fracture in the last six months;
11. Serious illnesses and life expectancy\<2 years;
12. Allergic to study drugs;
13. Used any study drug or device within 30 days before randomization or within the drug half-life (whichever is longer);
14. Failure to take medication as required;
15. Replacement surgery in the near future;
16. Contraindications to MRI scans (e.g. implanted pacemakers, metal sutures, shrapnel or iron filings in the eyes, claustrophobia, knees too large to use coils);
17. Sensitive to or unsuitable for X-ray exposure (e.g. aplastic anemia, etc);
18. Poor dental health or dental surgery in the near future.
50 Years
75 Years
ALL
No
Sponsors
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CSPC Ouyi Pharmaceutical Co., Ltd.
INDUSTRY
Peking Union Medical College Hospital
OTHER
Responsible Party
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Locations
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Peking Union Medical College Hospital
Beijing, , China
The Third Affiliated Hospital of Southern Medical University
Guangzhou, , China
Zhongshan Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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References
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Peng HM, Weng XS, Li Y, Feng B, Qian W, Cai DZ, Zhao C, Yao ZJ, Yang Y, Zhang C, Wan S. Effect of alendronate sodium plus vitamin D3 tablets on knee joint structure and osteoarthritis pain: a multi-center, randomized, double-blind, placebo-controlled study protocol. BMC Musculoskelet Disord. 2022 Jun 17;23(1):584. doi: 10.1186/s12891-022-05521-4.
Other Identifiers
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Peking UMCH
Identifier Type: -
Identifier Source: org_study_id
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