Male Osteoporosis or Osteopenia
Conditions
Interventions
Denosumab Group:Injection of denosumab, and supplementation of calcium and vitamin D
Control Group:Supplementation of calcium and vitamin D
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
Male
Age
40 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Adult males aged 40 years and older with a history of fragility fracture of the hip or vertebral body (with no time limit for occurrence); 2. The patient has signed the informed consent form; 3. Males under 50 years of age with a bone mineral density (BMD) Z-score <= -2.0 at the total hip, femoral neck, or lumbar spine (L1-4); 4. Males aged 50 years and older with a bone mineral density (BMD) T-score <= -1.0 at the total hip, femoral neck, or lumbar spine (L1-4).
Exclusion criteria
Exclusion criteria: 1. Diagnosis of other metabolic bone diseases, such as hyperparathyroidism, Paget's disease of bone, osteomalacia, osteogenesis imperfecta, etc. 2. Severe hepatic or renal insufficiency: serum alkaline phosphatase level higher than 1.5 times the upper limit of normal, or alanine aminotransferase greater than 3 times the upper limit of normal, or calculated creatinine clearance rate 7.5%); 4. Hereditary lipid metabolism disorders such as familial hypertriglyceridemia and familial hypercholesterolemia; 5. Connective tissue diseases such as rheumatoid arthritis and systemic lupus erythematosus; 6. Metastatic solid tumors or hematological malignancies; 7. Contraindications to denosumab: hypocalcemia, hypersensitivity to the active ingredient of denosumab or any of its excipients; 8. Receipt of denosumab, bisphosphonates, teriparatide, or romosozumab within 1 year; receipt of glucocorticoid therapy for more than 3 months within 6 months; use of thiazolidinediones, vitamin K2, calcitonin, anabolic steroids, or growth hormone within 6 months; 9. Traumatic fractures caused by external force.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone Turnover Markers(BTMs);Bone Mineral Density(BMD); | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiac troponin(cTn);Lipid Metabolism Indicators;Glucose Metabolism Indicators;Degree of Vascular Calcification;Lateral X-ray Films of the Thoracic and Lumbar Spine and X-rays of Fracture Sites;Chair Stand Test(CST);Trabecular Bone Score(TBS);Visual Analogue Scale(VAS)Pain Score;Inflammatory Indicators;Screening Indicators for the Etiology of Secondary Osteoporosis;Muscle Mass;Sex Hormone Levels;Lifestyle;Routine Blood and Urine Tests;New-onset Fractures;Cardiometabolic Index(CMI);Calcium-Phosphorus Metabolism Indicators;Hepatic and Renal Function;Health-Related Quality of Life(HR-QoL)Score;Grip Strength; | — |
Countries
China
Contacts
Public ContactLi Mei
Peking Union Medical College Hospital
Outcome results
None listed