A Study of Alendronate Sodium Vitamin D3 Tablets on Knee Osteoarthritis

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04739592

Collaborator

CSPC Ouyi Pharmaceutical Co., Ltd. (Industry)

Enrollment

Locations

Arms

35.8

Anticipated Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Drug: alendronate sodium vitamin D3 tablets Drug: Placebo	Phase 4

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 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Jul 7, 2021

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: alendronate sodium vitamin D3 tablets participants will receive alendronate sodium vitamin D3 tablets once per week for one year.	Drug: alendronate sodium vitamin D3 tablets once per week for one year
Placebo Comparator: placebo participants will receive a placebo tablet once per week for one year.	Drug: Placebo once per week for one year

Arm

Intervention/Treatment

Experimental: alendronate sodium vitamin D3 tablets

participants will receive alendronate sodium vitamin D3 tablets once per week for one year.

Drug: alendronate sodium vitamin D3 tablets

once per week for one year

Placebo Comparator: placebo

participants will receive a placebo tablet once per week for one year.

Drug: Placebo

once per week for one year

Outcome Measures

Primary Outcome Measures

WORMS score of knee joint MRI [The sixth month]
WORM score of participants at the sixth month after enrollment
WORMS score of knee joint MRI [The 12th month]
WORM score of participants at the 12th month after enrollment

Secondary Outcome Measures

WORMS score of knee joint MRI [The 24th month]
WORM score of patients at the 24th month after enrollment
Pain intensity and symptom record [The second week]
Pain intensity and symptom record of patients at the second week after enrollment
Pain intensity and symptom record [The 4th week]
Pain intensity and symptom record of patients at the 4th week after enrollment
Pain intensity and symptom record [The 8th week]
Pain intensity and symptom record of patients at the 8th week after enrollment
Pain intensity and symptom record [The 12th week]
Pain intensity and symptom record of patients at the 12th week after enrollment
Quality of life (the MOS item short from health survey,SF-36 ) [The third month]
SF-36 scale of patients at the third month after enrollment
Quality of life (the MOS item short from health survey,SF-36 ) [The sixth month]
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
Quality of life (the MOS item short from health survey,SF-36 ) [The 12th month]
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
bone density (lumbar spine, hip joint and knee joint) [The 12th month]
bone density of patients at the 12th month after enrollment
bone density (lumbar spine, hip joint and knee joint) [The 24th month]
bone density of patients at the 24th month after enrollment
Risk of knee replacement [The 12th month]
Risk of knee replacement of patients at the 12th month after enrollment
Risk of knee replacement [The 24th month]
Risk of knee replacement of patients at the 24th month after enrollment
Kellgren & Lawrence(KL) grading Score [The 12th month]
KL-grading Score of patients at the 12th month after enrollment, 0 to Ⅳ, higher scores mean a worse outcome
Kellgren & Lawrence(KL) grading Score [The 24th month]
KL-grading Score of patients at the 12th month after enrollment, 0 to Ⅳ, higher scores mean a worse outcome
Serum IL-6, TNF-a, erythrocyte sedimentation rate, C-reactive protein [The third month]
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.
Serum IL-6, TNF-a, erythrocyte sedimentation rate, C-reactive protein [The sixth month]
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.
Serum IL-6, TNF-a, erythrocyte sedimentation rate, C-reactive protein [The 12th month]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Locations

	Site	City	Country
1	Peking Union Medical College Hospital	Beijing	China
2	The Third Affiliated Hospital of Southern Medical University	Guangzhou	China
3	Zhongshan Hospital	Shanghai	China