Overview

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

Status:
NOT_YET_RECRUITING

Trial end date:
2026-07-31

Target enrollment:

Participant gender:

Summary

This research project is launched in response to the significant issue of the lack of a systematic management system for type 2 diabetes mellitus (T2DM) with osteoporosis. The study will enroll patients with T2DM and high fracture risk and conduct a prospective, multicenter, randomized controlled trial. The control group will be treated with alendronate, while the intervention group will receive denosumab treatment, both for a period of one year. The primary endpoint is the change rate of lumbar bone density at 12 months of treatment. The research objective of this project is to clarify the intervention effect of denosumab on patients with T2DM and high fracture risk, to provide references for the clinical diagnosis and treatment of T2DM, and to effectively reduce the incidence of osteoporotic fractures, thereby substantially reducing the harm of the disease to national health and the socio-economic situation. This study will provide important clinical research evidence for the formulation and implementation of prevention and control strategies for major chronic diseases such as diabetes and osteoporosis in our country.

Phase:

Details

Lead Sponsor:

Peking Union Medical College Hospital