A Study of Alendronate Sodium Vitamin D3 Tablets on Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

The Effect of Alendronate Sodium Vitamin D3 Tablets on Knee Joint Structure and Knee Osteoarthritis Pain: A Multi-center, Randomized, Double-blind, Controlled Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04739592
• Other study ID #: Peking UMCH
• Status: Recruiting
• Phase: Phase 4
• Start date: July 7, 2021
• Est. completion date: July 2024

Study information

• Verified date: September 2021
• Source: Peking Union Medical College Hospital
• Contact: Huiming Peng
• Phone: 13601276089
• Email: penghuiming[@]139.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2024
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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 of Rheumatology (ACR) and Chinese Orthopaedic Association);

5. Kellgren-Lawrence grading?or?in X-ray;

Exclusion Criteria:

1. Other forms of active arthritis (such as rheumatoid arthritis or other inflammatory arthritis);

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• alendronate sodium vitamin D3 tablets
once per week for one year
• Placebo
once per week for one year

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing
China	The Third Affiliated Hospital of Southern Medical University	Guangzhou
China	Zhongshan Hospital	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	CSPC Ouyi Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WORMS score of knee joint MRI	WORM score of participants at the sixth month after enrollment	The sixth month
Primary	WORMS score of knee joint MRI	WORM score of participants at the 12th month after enrollment	The 12th month
Secondary	WORMS score of knee joint MRI	WORM score of patients at the 24th month after enrollment	The 24th month
Secondary	Pain intensity and symptom record	Pain intensity and symptom record of patients at the second week after enrollment	The second week
Secondary	Pain intensity and symptom record	Pain intensity and symptom record of patients at the 4th week after enrollment	The 4th week
Secondary	Pain intensity and symptom record	Pain intensity and symptom record of patients at the 8th week after enrollment	The 8th week
Secondary	Pain intensity and symptom record	Pain intensity and symptom record of patients at the 12th week after enrollment	The 12th week
Secondary	Quality of life (the MOS item short from health survey,SF-36 )	SF-36 scale of patients at the third month after enrollment	The third month
Secondary	Quality of life (the MOS item short from health survey,SF-36 )	SF-36 scale of patients at the sixth month after enrollment. The score is calculated from eight dimensions, with the higher the final score the better	The sixth month
Secondary	Quality of life (the MOS item short from health survey,SF-36 )	SF-36 scale of patients at the 12th month after enrollment. The score is calculated from eight dimensions, with the higher the final score the better	The 12th month
Secondary	bone density (lumbar spine, hip joint and knee joint)	bone density of patients at the 12th month after enrollment	The 12th month
Secondary	bone density (lumbar spine, hip joint and knee joint)	bone density of patients at the 24th month after enrollment	The 24th month
Secondary	Risk of knee replacement	Risk of knee replacement of patients at the 12th month after enrollment	The 12th month
Secondary	Risk of knee replacement	Risk of knee replacement of patients at the 24th month after enrollment	The 24th month
Secondary	Kellgren & Lawrence(KL) grading Score	KL-grading Score of patients at the 12th month after enrollment, 0 to ?, higher scores mean a worse outcome	The 12th month
Secondary	Kellgren & Lawrence(KL) grading Score	KL-grading Score of patients at the 12th month after enrollment, 0 to ?, higher scores mean a worse outcome	The 24th month
Secondary	Serum IL-6, TNF-a, erythrocyte sedimentation rate, C-reactive protein	Serum inflammatory factor of patients at the third month after enrollment, IL-6 and TNF-a were measured in pg/ml,erythrocyte sedimentation rate was measured in mm/h, C-reactive protein was measured in mg/dL.	The third month
Secondary	Serum IL-6, TNF-a, erythrocyte sedimentation rate, C-reactive protein	Serum inflammatory factor of patients at the sixth month after enrollment, IL-6 and TNF-a were measured in pg/ml,erythrocyte sedimentation rate was measured in mm/h, C-reactive protein was measured in mg/dL.	The sixth month
Secondary	Serum IL-6, TNF-a, erythrocyte sedimentation rate, C-reactive protein	Serum inflammatory factor of patients at the 12th month after enrollment, IL-6 and TNF-a were measured in pg/ml,erythrocyte sedimentation rate was measured in mm/h, C-reactive protein was measured in mg/dL.	The 12th month