Osteoarthritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Age above 50 years old, gender is not limited; (2) Meet the diagnostic criteria for osteoarthritis of the knee in the Osteoarthritis Diagnostic and Treatment Guidelines (2018 edition); (3) Study side knee 100 mm visual analog scale (VAS) pain scores (movement status: walking) at baseline at screening were all 40 mm <= VAS < 80 mm, and the study side was defined as the side with the higher knee pain score at screening; (4) According to the WHO recommended diagnostic criteria for osteoporosis, bone mineral density (BMD) was detected by dual-energy X-ray absorptiometry (DXA), -2.5 < T-score < -1.0; (5) Non-habitual physical activity may be avoided from the start of the screening period and throughout the trial treatment period.
Exclusion criteria
Exclusion criteria: (1) Suffering from heart, liver, lung, kidney and other important organ diseases, blood diseases, tumor diseases, etc.; (2) Subjects with major mental illness, difficulty in controlling their behavior, and inability to cooperate; (3) Suffering from other types of bone and joint diseases and various diseases that may affect bone metabolism; (4) Those who have had open joint injury to the knee joint or have undergone other knee joint surgeries such as arthroscopy, arthroscopic dissection, and knee arthroplasty in the past 1 year; (5) Received intra-articular drug injection therapy (such as glucocorticoids, sodium hyaluronate, medical chitose, growth factors, platelet-rich plasma, etc.) in the past 3 months; (6) Use of Chinese and Western drugs for the treatment of osteoarthritis in the past 1 week, such as slow-acting drugs to relieve OA symptoms (diacerein, glucosamine, chondroitin sulfate, etc.), antineuralgia drugs (gabapentin, pregabalin, etc.), Chinese patent medicines (including artificial tiger bone powder, gold iron lock and other active ingredients) and other oral drugs and external preparations; (7) Those who have a history of taking calcium, vitamin D, anti-OP drugs and other drugs that affect bone metabolism in the past 2 weeks; (8) Patients with clinical diagnosis of gout or high uric acid; (9) Pregnant and lactating women and those who have a birth plan within 3 months; (10) Those who are judged by the investigator to be unsuitable to participate in this trial or are prone to loss to follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Delayed Gadolinium-Enhanced MRI of Cartilage (dGEMRIC)?; | — |
Secondary
| Measure | Time frame |
|---|---|
| 100 mm Visual Analogue Scale (VAS);Knee Osteoarthritis WOMAC Score;Health Assessment Questionnaire Index;Somatic function;Bone Metabolism Markers; | — |
Countries
China
Contacts
The People's Hospital of Chizhou