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NCT07063797
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Study on the Intervention Effect of Denosumab on High-Risk Patients With Osteoporotic Fractures in Type 2 Diabetes

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

358

Start Date

2026-02-01

Completion Date

2027-07-31

Last Updated

2026-01-21

Healthy Volunteers

No

Interventions

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.

Locations (4)

Peking Union Medical College Hospital

Beijing, Dongcheng, China

Huai'an First People's Hospital

Huai'an, China

Jiangxi Provincial People's Hospital

Jiangxi, China

Kunshan Hospital of Traditional Chinese Medicine

Kunshan, China