NCT07063797

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 358 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes
• Osteoporosis
• Fractures

Interventions

Type	Name	Description
DRUG	Denosumab treatment in type 2 diabetes mellitus (T2DM) with osteoporosis patients	1. Antihyperglycemic drug therapy: Follow the Chinese Diabetes Treatment Guidelines and clinical practice standards. Adjust the antihyperglycemic regimen based on blood glucose levels, with a target HbA1c of below 7.5%. 2. Denosumab treatment: Administer 60 mg of denosumab via subcutaneous injection every six months for a total treatment period of one year.
DRUG	Denosumab combined with eldecalcitol treatment in type 2 diabetes mellitus (T2DM) with osteoporosis patients	1. Antihyperglycemic drug therapy: Follow the Chinese Diabetes Treatment Guidelines and clinical practice standards. Adjust the antihyperglycemic regimen based on blood glucose levels, with a target HbA1c of below 7.5%. 2. Denosumab injection (Mai Lishu), 60 mg subcutaneous injection, once every six months, combined with eldecalcitol soft capsules (Gai Sheng Yuan), 0.75 μg/capsule, take one capsule orally once daily, for one year of treatment.

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-07-31
• Completion: 2027-07-31
• First posted: 2025-07-14
• Last updated: 2026-01-21

Locations

4 sites across 1 country: China