Periprosthetic Bone Loss After Hip Arthroplasty
Conditions
Interventions
Medication Group:Romosozumab subcutaneous injection
Sponsors
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
Female
Age
55 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Postmenopausal women aged 55–80; 2. Proximal femur Dorr classification is type A or B; 3. Unilateral cementless primary hip replacement is required due to femoral neck fracture, hip osteoarthritis, avascular necrosis of the femoral head, or developmental dysplasia of the hip; 4. Osteoporosis with a high risk of fractures; 5. Physically fit for surgery; 6. Patients and the legal representative fully understand the content of the trial and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Secondary osteoporosis or other diseases affecting bone metabolism; 2. Combine rheumatoid arthritis, ankylosing spondylitis, and other diseases that may affect the bone density around prostheses; 3. The affected side has a history of hip surgery; 4. Medication affecting bone metabolism taken within the past year (glucocorticoids, cyclosporine, anticancer drugs, thyroid hormones or their analogs, etc.); 5. Allergic to the study drug or its ingredients; 6. Severe heart, lung, liver, or kidney dysfunction, or malignant tumors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in periprosthetic bone mineral density (BMD) in Gruen zone 1; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage changes in lumbar spine, total hip, and Gruen zones 2-7 BMD;Percentage changes in bone metabolism markers (?-CTX, P1NP), blood calcium, and vitamin D;Changes in Harris Hip Score and quality of life score (EQ-5D) relative to baseline;Imaging parameters for prosthetic joint loosening: acetabular cup anteversion and abduction angles, femoral stem subsidence, horizontal and vertical displacement of the acetabular cup;Overall incidence of adverse events after hip replacement surgery in osteoporosis patients during romosozumab treatment; | — |
Countries
China
Contacts
Public ContactDing Yue
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Outcome results
None listed