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

Not Applicable

Not yet recruiting

• Conditions: Type 2 Diabetes; Osteoporosis; Fractures
• Interventions: Drug: Denosumab treatment in type 2 diabetes mellitus (T2DM) with osteoporosis patients; Drug: Eldecalcitol treatment in type 2 diabetes mellitus (T2DM) with osteoporosis patients

• Registration Number: NCT07063797
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-06-17
• Study First Submitted QC: 2025-07-02
• Last Update Submitted: 2025-07-02
• Study First Posted: 2025-07-14
• Last Update Posted: 2025-07-14
• Study Start: 2025-08-01
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 310

Inclusion Criteria

1. Confirmed diagnosis of type 2 diabetes (based on the "China Guidelines for the Prevention and Treatment of Diabetes (2024 Edition)");
2. Males aged ≥50 years; females aged ≥45 years and postmenopausal for more than 2 years;
3. Duration of diabetes>10 years; or presence of microvascular complications (diabetic retinopathy stage III or above, or diabetic nephropathy (urinary albumin-to-creatinine ratio (UACR)≥30 mg/g, or estimated glomerular filtration rate (eGFR) <60 ml/min/(1.73m²)); or macrovascular complications (coronary atherosclerotic heart disease or cerebrovascular disease);
4. History of hip or vertebral fragility fractures; or history of fragility fractures at other sites (excluding the skull, feet, and hands) with a T-score of <-1.0 at the femoral neck, total hip, or any L1-L4 site; or a T-score of <-2.0 at the femoral neck, total hip, or any L1-L4 site;
5. Signed informed consent form, willing to participate in the study

Exclusion Criteria

1. Diseases that cause secondary osteoporosis: a. Various metabolic bone diseases, such as osteomalacia, primary hyperparathyroidism, osteogenesis imperfecta, Paget's disease, etc.; b. Cushing's syndrome; c. Hyperprolactinemia; d. Others;
2. Malignant tumors within the past 5 years, except for those expected to be cured after treatment (e.g., completely resected in situ basal cell or squamous cell carcinoma of the skin, cervical cancer, or ductal carcinoma of the breast);
3. Received intravenous bisphosphonate treatment within the past 2 years or oral bisphosphonate treatment within the past 1 year;
4. History or current diagnosis of osteomyelitis or osteonecrosis of the jaw; unhealed dental or oral surgical wounds; acute dental or jaw conditions requiring oral surgery; planned to undergo invasive dental surgery during the study period;
5. Received denosumab, teriparatide, or romosozumab treatment within the past 6 months;
6. Continuous use of calcitonin for more than 3 months within the past year;
7. Use of glucocorticoids (equivalent to>5 mg/day prednisone) for more than 10 days within the past 6 weeks;
8. 25-hydroxyvitamin D<20 ng/mL;
9. Active infections requiring systemic treatment;
10. Uncontrolled comorbidities, including New York Heart Association (NYHA) functional class III or above heart failure, severe arrhythmias, severe hepatic insufficiency (alanine aminotransferase or aspartate aminotransferase>3 times the upper limit of normal), severe renal insufficiency (eGFR<30 ml/min/1.73 m²);
11. Hypocalcemia, hypercalcemia, or hypercalciuria;
12. Allergy to the study drug;
13. Currently participating in other clinical trials of drugs;
14. Subjects deemed unsuitable for enrollment in this study by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Denosumab treatment group	Denosumab treatment in type 2 diabetes mellitus (T2DM) with osteoporosis patients	Administer 60 mg of denosumab via subcutaneous injection every six months for a total treatment period of one year.
Eldecalcitol treatment group	Eldecalcitol treatment in type 2 diabetes mellitus (T2DM) with osteoporosis patients	Eldecalcitol, 0.75 µg per capsule, taken orally once daily for a total treatment period of one year.

Primary Outcome Measures

Name	Time	Method
change rate of lumbar bone density	12 months of treatment	DXA measurement

Secondary Outcome Measures

Name	Time	Method
Incidence of osteoporotic fractures	12 months of treatment	X ray imaging measurement
Change rate of serum levels of β-CTX	12 months of treatment	electrochemiluminescence measurment
Change rate of bone density in the femoral neck and total hip	12 months of treatment	DXA measurement
Change rate of serum levels of PINP	12 months of treatment	electrochemiluminescence measurment

Trial Locations

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