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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
once per week for one year
once per week for one year
Peking Union Medical College Hospital
Beijing, China
RECRUITINGThe Third Affiliated Hospital of Southern Medical University
Guangzhou, China
RECRUITINGZhongshan Hospital
Shanghai, China
RECRUITINGWORMS score of knee joint MRI
WORM score of participants at the sixth month after enrollment
Time frame: The sixth month
WORMS score of knee joint MRI
WORM score of participants at the 12th month after enrollment
Time frame: The 12th month
WORMS score of knee joint MRI
WORM score of patients at the 24th month after enrollment
Time frame: The 24th month
Pain intensity and symptom record
Pain intensity and symptom record of patients at the second week after enrollment
Time frame: The second week
Pain intensity and symptom record
Pain intensity and symptom record of patients at the 4th week after enrollment
Time frame: The 4th week
Pain intensity and symptom record
Pain intensity and symptom record of patients at the 8th week after enrollment
Time frame: The 8th week
Pain intensity and symptom record
Pain intensity and symptom record of patients at the 12th week after enrollment
Time frame: The 12th week
Quality of life (the MOS item short from health survey,SF-36 )
SF-36 scale of patients at the third month after enrollment
Time frame: The third month
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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
Time frame: The sixth month
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
Time frame: The 12th month
bone density (lumbar spine, hip joint and knee joint)
bone density of patients at the 12th month after enrollment
Time frame: The 12th month
bone density (lumbar spine, hip joint and knee joint)
bone density of patients at the 24th month after enrollment
Time frame: The 24th month
Risk of knee replacement
Risk of knee replacement of patients at the 12th month after enrollment
Time frame: The 12th month
Risk of knee replacement
Risk of knee replacement of patients at the 24th month after enrollment
Time frame: The 24th month
Kellgren & Lawrence(KL) grading Score
KL-grading Score of patients at the 12th month after enrollment, 0 to Ⅳ, higher scores mean a worse outcome
Time frame: The 12th month
Kellgren & Lawrence(KL) grading Score
KL-grading Score of patients at the 12th month after enrollment, 0 to Ⅳ, higher scores mean a worse outcome
Time frame: The 24th month
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.
Time frame: The third month
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.
Time frame: The sixth month
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.
Time frame: The 12th month