Study on the Intervention Effect of Denosumab on High-Risk Patients With Osteoporotic Fractures in Type 2 Diabetes

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Jul 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how well a medicine called denosumab works to protect bones in people who have type 2 diabetes and are at high risk of breaking bones due to osteoporosis, a condition that makes bones weak and fragile. The study will compare denosumab to another common treatment called alendronate over one year to see which one better improves bone strength in the lower back area. The goal is to find better ways to prevent fractures, which can be serious for people with diabetes and weak bones.

People who might join the study are adults with type 2 diabetes who are at least 50 years old for men, or women at least 45 years old and have been through menopause for more than two years. They should have had diabetes for over 10 years or have certain diabetes-related complications, and a history of bone fractures or evidence of weak bones based on bone density tests. Participants will receive either denosumab or alendronate treatment for one year and will be monitored to see how their bone density changes. The study is not yet recruiting, and those interested must meet specific health criteria and agree to take part. This research aims to help doctors better manage bone health in people with diabetes and reduce the chances of fractures in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Confirmed diagnosis of type 2 diabetes (based on the "China Guidelines for the Prevention and Treatment of Diabetes (2024 Edition)");
• • 2. Males aged ≥50 years; females aged ≥45 years and postmenopausal for more than 2 years;
• • 3. Duration of diabetes\>10 years; or presence of microvascular complications (diabetic retinopathy stage III or above, or diabetic nephropathy (urinary albumin-to-creatinine ratio (UACR)≥30 mg/g, or estimated glomerular filtration rate (eGFR) \<60 ml/min/(1.73m²)); or macrovascular complications (coronary atherosclerotic heart disease or cerebrovascular disease);
• • 4. History of hip or vertebral fragility fractures; or history of fragility fractures at other sites (excluding the skull, feet, and hands) with a T-score of \<-1.0 at the femoral neck, total hip, or any L1-L4 site; or a T-score of \<-2.0 at the femoral neck, total hip, or any L1-L4 site;
• • 5. Signed informed consent form, willing to participate in the study
• Exclusion Criteria:
• • 1. Diseases that cause secondary osteoporosis: a. Various metabolic bone diseases, such as osteomalacia, primary hyperparathyroidism, osteogenesis imperfecta, Paget's disease, etc.; b. Cushing's syndrome; c. Hyperprolactinemia; d. Others;
• • 2. Malignant tumors within the past 5 years, except for those expected to be cured after treatment (e.g., completely resected in situ basal cell or squamous cell carcinoma of the skin, cervical cancer, or ductal carcinoma of the breast);
• • 3. Received intravenous bisphosphonate treatment within the past 2 years or oral bisphosphonate treatment within the past 1 year;
• • 4. History or current diagnosis of osteomyelitis or osteonecrosis of the jaw; unhealed dental or oral surgical wounds; acute dental or jaw conditions requiring oral surgery; planned to undergo invasive dental surgery during the study period;
• • 5. Received denosumab, teriparatide, or romosozumab treatment within the past 6 months;
• • 6. Continuous use of calcitonin for more than 3 months within the past year;
• • 7. Use of glucocorticoids (equivalent to\>5 mg/day prednisone) for more than 10 days within the past 6 weeks;
• • 8. 25-hydroxyvitamin D\<20 ng/mL;
• • 9. Active infections requiring systemic treatment;
• • 10. Uncontrolled comorbidities, including New York Heart Association (NYHA) functional class III or above heart failure, severe arrhythmias, severe hepatic insufficiency (alanine aminotransferase or aspartate aminotransferase\>3 times the upper limit of normal), severe renal insufficiency (eGFR\<30 ml/min/1.73 m²);
• • 11. Hypocalcemia, hypercalcemia, or hypercalciuria;
• • 12. Allergy to the study drug;
• • 13. Currently participating in other clinical trials of drugs;
• • 14. Subjects deemed unsuitable for enrollment in this study by the investigator.