A Study of Alendronate Sodium Vitamin D3 Tablets on Knee Osteoarthritis

Last updated: April 21, 2022
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Knee Injuries

Osteoarthritis

Treatment

N/A

Clinical Study ID

NCT04739592
Peking UMCH
  • Ages 50-75
  • All Genders

Study 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 osteoarthritis. The treatment period of this study is one year and followed-up period is 2 years. The results of knee joint MRI will be evaluated by using the WORMS score.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with significant knee pain (pain score≥40mm on the 100mmVAS scale);
  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 ofRheumatology (ACR) and Chinese Orthopaedic Association);
  5. Kellgren-Lawrence gradingⅠorⅡin X-ray;

Exclusion

Exclusion Criteria:

  1. Other forms of active arthritis (such as rheumatoid arthritis or other inflammatoryarthritis);
  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 orcancer;
  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 drughalf-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 oriron 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.

Study Design

Total Participants: 60
Study Start date:
July 07, 2021
Estimated Completion Date:
July 31, 2024

Study 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 course of alendronate sodium vitamin D3 tablets or placebo. 1:1 double blinded randomisation will be undertaken. This study plans to enroll 60 participants and will be carried out in three domestic centers (Peking Union Medical College Hospital, Zhongshan Hospital and The Third Affiliated Hospital of Southern Medical University) with a follow-up period of 2 years.

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.

Connect with a study center

  • Peking Union Medical College Hospital

    Beijing,
    China

    Active - Recruiting

  • The Third Affiliated Hospital of Southern Medical University

    Guangzhou,
    China

    Active - Recruiting

  • Zhongshan Hospital

    Shanghai,
    China

    Active - Recruiting

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