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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Denosumab treatment group | Active Comparator | Administer 60 mg of denosumab via subcutaneous injection every six months for a total treatment period of one year. |
|
| Denosumab combined with eldecalcitol treatment group | Experimental | Denosumab 60 mg subcutaneous injection, once every six months, combined with eldecalcitol 0.75 μg once daily, for one year of treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Denosumab treatment in type 2 diabetes mellitus (T2DM) with osteoporosis patients | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| change rate of lumbar bone density | DXA measurement | 12 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of osteoporotic fractures | X ray imaging measurement | 12 months of treatment |
| Change rate of bone density in the femoral neck and total hip | DXA measurement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weibo Xia, MD | Contact | 13501002126 | xiaweibo8301@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Dongcheng | 100730 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 5, 2025 | Jan 12, 2026 |
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|
| Denosumab combined with eldecalcitol treatment in type 2 diabetes mellitus (T2DM) with osteoporosis patients | Drug |
|
|
| 12 months of treatment |
| Change rate of serum levels of β-CTX | electrochemiluminescence measurment | 6 months of treatment |
| Change rate of serum levels of β-CTX | electrochemiluminescence measurment | 12 months of treatment |
| Change rate of serum levels of PINP | electrochemiluminescence measurment | 6 months of treatment |
| Change rate of serum levels of PINP | electrochemiluminescence measurment | 12 months of treatment |
| Huai'an First People's Hospital | Huai'an | China |
|
| Jiangxi Provincial People's Hospital | Jiangxi | China |
|
| Kunshan Hospital of Traditional Chinese Medicine | Kunshan | China |
|
| Prot_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 5, 2025 | Jan 14, 2026 | ICF_003.pdf |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D010024 | Osteoporosis |
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D014947 | Wounds and Injuries |
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