Giant cell tumor of bone, multiple myeloma or solid tumor with bone metastasis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed giant cell tumor of bone, multiple myeloma or bone metastasis of solid tumors, including but not limited to lung cancer, breast cancer, intestinal cancer, prostate cancer, liver cancer, esophageal cancer, etc., and need to be treated with denosumab; 2. Undergo imaging examinations such as computed tomography (CT), magnetic resonance imaging (MRI), X-ray, etc., indicating at least one bone metastasis or characteristic osteolytic lesion; 3. Age>=18 years old; 4. The performance status score of the Eastern Cooperative Oncology Group (ECOG) in the United States is 0-2; 5. Estimated survival time>=6 months.
Exclusion criteria
Exclusion criteria: 1. Severe heart, liver, kidney, lung and brain insufficiency; 2. Pregnant and lactating women; 3. Patients who are allergic to the study drug or who are prohibited from using the study drug in the instructions; 4. Have suffered or are currently suffering from osteomyelitis or osteonecrosis of the jaw; Dental or jaw disease in the active phase that requires oral surgery; Dental surgery or oral surgery wounds that have not healed; 5. Those with incomplete clinical data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Types, frequency, and time of occurrence of bone related events (SREs) within 6 months.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Types, frequency, and time of occurrence of bone related events (SREs) within 3 months;;At 3 and 6 months of treatment, serum calcium and phosphate ion concentrations, as well as serum alkaline phosphatase (ALP) levels, were compared to baseline;Compared to baseline bone density levels at 6 months of treatment;The median time from the first to the second SRE of the same type during the study period;Number of exacerbations of bone pain within 6 months;Types and severity of adverse reactions; | — |
Countries
China
Contacts
Zhengzhou People's Hospital