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

NCT07063797 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 358

Last updated 2026-01-21

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07063797 on ClinicalTrials.gov