Steroid-Induced Osteonecrosis of the Femoral Head
Conditions
Interventions
positive control group:Oral Alendronate Sodium Tablets
Experimental Group:Oral Tongluoshenggu Capsule
Sponsors
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1)Age must be between 18 and 60 years inclusive with no gender restriction. (2)Must meet the clinical diagnosis of SONFH and also conform to the ARCO staging II diagnosis for SONFH. (3)Must be in accordance with the TCM diagnosis of phlegm and blood stasis obstructing the collaterals. (4)Must be capable of understanding and signing the informed consent document for this study.
Exclusion criteria
Exclusion criteria: (1)ONFH not caused by medication or where the etiology of the condition cannot be identified. (2)Diagnosed with metabolic bone diseases other than osteonecrosis such as Paget's disease osteogenesis imperfecta primary hyperparathyroidism fibrous monostotic dysplasia and osteopetrosis. (3)Has undergone hip replacement surgery has other hip diseases neuropathy of the lower limbs or collapse-related conditions. (4)Suffering from other infectious diseases such as septic arthritis ankylosing spondylitis Kashin-Beck disease pigmented villonodular synovitis and tuberculosis of the hip. (5)Allergic to the study drug or has contraindications to the study drug: hypocalcemia (serum calcium less than 8 mg/dl or 2.0 mmol/L) urticaria angioedema inability to stand or sit upright for at least 30 minutes esophageal abnormalities causing delayed esophageal emptying (such as esophageal stricture or achalasia). (6)Has contraindications for magnetic resonance imaging (MRI) such as having internal devices incompatible with MRI (pacemakers aneurysm clips etc.). (7)Has participated in or is currently participating in other clinical trials within the last 3 months. (8)Pregnant breastfeeding or planning to become pregnant. (9)Suffering from diseases that the researchers believe would prevent the participant from completing the study such as stress fractures coagulation disorders history of malignancy critical illness history of sepsis history of HIV infection chronic liver failure hepatitis serology positive chronic renal failure (creatinine clearance less than 35.0 mL/min) serious heart disease (such as atrial fibrillation) mental disorders. (10)Currently undergoing active cancer treatment or hematological malignancy or has received chemotherapy radiotherapy or immunotherapy for cancer in the past 2 years or is using anticoagulants immunosuppressants cytotoxic drugs or other drugs that cannot be discontinued during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiological efficacy score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Harris Hip score;bone morphogenetic protein (BMP)2;vascular endothelial growth factor(VEGF);The clinical efficacy rate;IL-6;EuroQol five dimensions five levels(EQ-5D-5L);transforming growth factor (TGF)-ß;procollagen I N-terminal propeptid(PINP);VAS scores;hypoxia-inducible factor (HIF)-1a;tumor necrosis factor(TNF)-a;walking distance score;hip flexion function score;interleukin(IL)-1ß; | — |
Countries
China
Contacts
Public ContactLi Bo
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of Traditional Chinese Medicine
Outcome results
None listed