Multiple myeloma bone disease
Conditions
Interventions
Treatment group:denosumab/zoledronic acid and vitamin K2
Control group:denosumab/zoledronic acid
Sponsors
Chengdu Third People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged > 18 years; 2. Diagnosis of symptomatic multiple myeloma (bone marrow monoclonal plasma cell percentage >= 10% and/or tissue biopsy evidence of plasmacytoma, serum and/or urine presence of monoclonal M protein); 3. Diagnosis of nonsecretory multiple myeloma (bone marrow monoclonal plasma cell percentage >= 30% and/or tissue biopsy evidence of plasmacytoma with elevated serum free light chains at baseline level); 4. Preparing or undergoing anti-myeloma treatment; 5. Osteolytic lesion with a diameter of >= 10mm on CT or MRI scan.
Exclusion criteria
Exclusion criteria: 1. Uncorrected hypocalcemia (serum calcium < 2.75 mmol/L); 2. Smoldering myeloma; 3. Have had other tumors such as breast cancer, lung cancer and prostate cancer within the last 5 years; 4. Previous history of osteonecrosis of the jaw; 5. Recent history of tooth extraction, dental or periodontal infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of skeletal-related events;Diameter of osteolytic lesion on CT or MRI; | — |
Secondary
| Measure | Time frame |
|---|---|
| osteocalcin;ß-collagen carboxy-terminal peptide;Amino terminal peptide of type I collagen;bone mineral density;alkaline phosphatase; | — |
Countries
China
Contacts
Public ContactJing Tan
Outcome results
None listed