drugset / Trial / NCT07063797

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

NCT07063797

Not yet recruiting 358 enrolled Peking Union Medical College Hospital
RandomizedParallel-groupOpen-labelPrevention

Summary

This study will conduct a randomized controlled trial targeting patients with type 2 diabetes and a high risk of fractures. The aim is to evaluate the intervention effect of denosumab combined with edilossobulin on patients with a high risk of osteoporotic fractures due to type 2 diabetes, as well as its impact on bone density, bone turnover indicators, the risk of new fractures, and the risk of hypocalcemia. This will provide scientific evidence for clinical diagnosis and treatment, and offer important clinical research evidence for formulating national health policies.

Timeline

Start
2026-02-01
Primary completion
2027-07-31
Completion
2027-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Denosumab Monoclonal antibody 60 mg Subcutaneous
Subject Eldecalcitol Small molecule 0.75 ug Oral