NCT05866029招募中不适用
Efficacy of Sequential Denosumab After Teriparatide for 6 Months Compared With Denosumab Monotherapy in Reducing Risk of Osteoporotic Fractures in Patients With New Fractures: a Multicenter Randomized Controlled Trial (STAND Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,478
- 试验地点
- 58
- 主要终点
- The main study：The incidence of new vertebral fractures
研究概览
简要总结
This project anchors osteoporotic fractures, conduct registration and follow-up studies, and conduct prospective treatment studies. By registering for follow-up studies on osteoporotic fractures, it is planned to obtain epidemiological data through registration and follow-up studies; A prospective treatment study for patients with osteoporotic fractures is planned to explore effective treatment strategies through randomized controlled trials; To study biomarkers for osteoporotic refractures, we plan to establish a biomarker warning model through multi omics research; To study imaging biomarkers for osteoporotic refractures, a new imaging technology is proposed to establish an imaging omics warning model.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New brittle hip fractures;
- •New brittle vertebral fractures;
- •New other site fractures and/or total hip or neck of femur or L1-L4 T-value < -1.0;
- •Men or postmenopausal women;
- •Age 45-90 years old;
- •Ability to move autonomously
排除标准
- •bone metabolic diseases except for osteoporosis eg. a. (Osteogenesis Imperfecta, Paget's disease, Osteomalacia), b. Cushing's syndrome, c.hyperprolactinemia;
- •Having primary hyperparathyroidism or hypothyroidism;
- •Had or have osteomyelitis of the jaw or necrosis of the jaw;
- •GFR<30ml/min/1.73m2;
- •Active infection that requires systematic treatment;
- •Used intravenous bisphosphonate, fluoride, or strontium for osteoporosis within 2 years;
- •Used teriparatide and denosumab for osteoporosis within 6 months;
- •Used glucocorticoids (equivalent to >5 mg/day prednisone) for more than 10 days within 6 weeks;
- •The time gap between the first time and the last time oral bisphosphonate for osteoporosis less than 1 year( if used within one year, but the cumulative use is ≤ 1 month, the subject can be enrolled) ;
- •Patients with malignant tumors or bone metastases within 5 years, except tumors that are expected to be cured after treatment;
- •Have hypocalcemia and hypercalcemia;
- •Unexplained elevation of alkaline phosphatase;
- •A serious deficiency of vitamin D (25OHD <10ng/mL);
- •Patients who have previously received external radiation or radiation therapy with bone implants;
- •Uncontrolled comorbidities included heart failure above the New York cardiac Function Scale, glycosylated hemoglobin > 8.5%, and severe arrhythmias;
- •Planned pregnancy and lactation at present or during the study period;
- •Allergic to teriparatide and denosumab;
- •Participating in clinical trials of other drugs at present;
- •subjects do not suitable for this study
研究组 & 干预措施
60mg of Denosumab treatment
Active Comparator
Monotherapy with denosumab injection ( 60mg, subcutaneous injection, semi-annually) for 24 months.
干预措施: Denosumab (Drug)
Teriparatide was sequentially treated with Denosumab
Experimental
- Treatment with teriparatide injection ( 20ug, subcutaneous injection, once daily) for 6 months, followed by discontinuation of teriparatide and change to denosumab injection ( 60mg, subcutaneous injection, once every six months) and continued until the 24th month.
- Treatment with teriparatide injection ( 20ug, subcutaneous injection, once daily) for 12 months, followed by discontinuation of teriparatide and change to denosumab injection ( 60mg, subcutaneous injection, semi-annually) treatment continued until the 24th month.
干预措施: Denosumab (Drug)
Teriparatide was sequentially treated with Denosumab
Experimental
- Treatment with teriparatide injection ( 20ug, subcutaneous injection, once daily) for 6 months, followed by discontinuation of teriparatide and change to denosumab injection ( 60mg, subcutaneous injection, once every six months) and continued until the 24th month.
- Treatment with teriparatide injection ( 20ug, subcutaneous injection, once daily) for 12 months, followed by discontinuation of teriparatide and change to denosumab injection ( 60mg, subcutaneous injection, semi-annually) treatment continued until the 24th month.
干预措施: Teriparatide (Drug)
结局指标
主要结局
The main study：The incidence of new vertebral fractures
时间窗: Within 24 months of treatment
The main study：the incidence of new vertebral fractures (clinical and imaging) within 24 months of treatment
The sub study：The rate of change in BMD from baseline at lumbar spine in 24 months
时间窗: Within 24 months of treatment
次要结局
- The main study：New vertebral fractures in 12 months(Within 12 months of treatment)
- The main study：New hip fractures, new fractures at other sites, and all new fractures at 12 and 24 months(Within 12 months and 24 months of treatment)
- The main study：The rate of BMD change from the baseline at the lumbar spine, total hip, and femoral neck in 12 and 24 months;(Within 12 months and 24 months of treatment)
- The main study：The rate of changes from baseline in serum type 1 collagen cross-linked C-terminal peptide (β-CTX) and type 1 procollagen N-terminal propeptide (P1NP) at 6, 12, and 24 months(6, 12, and 24 months)
- The main study：The patients' adherence to treatment(24 months)
- The main study：Cost-effectiveness(24 months)
- The sub study：BMD change at lumbar spine in 12 months(Within 12 months of treatment)
- The sub study：BMD changes at total hip and femoral neck in 12 and 24 months(Within 12 months and 24 months of treatment)
- The sub study：Serum β-CTX and P1NP levels at 12 and 24 months(12 months and 24 months)
- The sub study：The incidence of new vertebral fractures, hip fractures, new fractures at other sites, and all new fractures in 12 and 24 months(Within 12 months and 24 months of treatment)
研究者
研究点 (58)
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