NCT07063797尚未招募不适用
Study on the Intervention Effect of Denosumab on High-Risk Patients With Osteoporotic Fractures in Type 2 Diabetes
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 358
- 试验地点
- 4
- 主要终点
- change rate of lumbar bone density
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of type 2 diabetes (based on the "China Guidelines for the Prevention and Treatment of Diabetes (2024 Edition)").
- •Males aged ≥50 years; females aged ≥45 years and postmenopausal for more than 2 years.
- •Duration of diabetes >10 years; or presence of at least one of the following conditions: ①diabetic retinopathy; ②urine albumin-to-creatinine ratio (UACR)≥ 30 mg/g; ③estimated glomerular filtration rate (eGFR)<60 mL/min/1.73 m²; ④coronary atherosclerotic heart disease; ⑤ischemic stroke; ⑥transient ischemic attack; ⑦ atherosclerosis of the carotid, cerebral, or lower-extremity arteries with ≥50% luminal stenosis.
- •Glycated hemoglobin (HbA1c) ≤ 8.0 % measured within 1 month
- •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.
- •In the BMD measurement at lumbar vertebrae L1-L4, at least two or more vertebral bodies must meet the evaluable criteria.
- •Signed informed consent form, willing to participate in the study
排除标准
- •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;
- •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);
- •Received intravenous bisphosphonate treatment within the past 2 years or oral bisphosphonate treatment within the past 1 year;
- •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;
- •Received denosumab, teriparatide, or romosozumab treatment within the past 6 months;
- •Continuous use of calcitonin for more than 3 months within the past year;
- •Use of glucocorticoids (equivalent to>5 mg/day prednisone) for more than 10 days within the past 6 weeks;
- •25-hydroxyvitamin D<10ng/mL;
- •Active infections requiring systemic treatment;
- •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);
- •Hypocalcemia, hypercalcemia, or hypercalciuria (Note: hypercalciuria is defined as a urinary calcium/creatinine ratio > 0.5 mg/mg, or 24-hour urinary calcium > 7.5 mmol).;
- •Allergy to the study drug;
- •Currently participating in other clinical trials of drugs;
- •Subjects deemed unsuitable for enrollment in this study by the investigator.
研究组 & 干预措施
Denosumab treatment group
Experimental
Administer 60 mg of denosumab via subcutaneous injection every six months for a total treatment period of one year.
干预措施: Denosumab treatment in type 2 diabetes mellitus (T2DM) with osteoporosis patients (Drug)
Eldecalcitol treatment group
Active Comparator
Eldecalcitol, 0.75 µg per capsule, taken orally once daily for a total treatment period of one year.
干预措施: Eldecalcitol treatment in type 2 diabetes mellitus (T2DM) with osteoporosis patients (Drug)
结局指标
主要结局
change rate of lumbar bone density
时间窗: 12 months of treatment
DXA measurement
次要结局
- Incidence of osteoporotic fractures(12 months of treatment)
- Change rate of serum levels of β-CTX(12 months of treatment)
- Change rate of bone density in the femoral neck and total hip(12 months of treatment)
- Change rate of serum levels of PINP(12 months of treatment)
研究者
研究点 (4)
Loading locations...
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