NCT06804590已完成3 期
A Randomized, Double-blind, Parallel-group, Phase III Study to Compare the Clinical Efficacy, Safety, and Immunogenicity of Denosumab Injection 9MW0311 With Prolia® in Postmenopausal Women With Osteoporosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline in lumbar spine(LS)-BMD at Week 53 （Month 12)
研究概览
简要总结
This study is a multicenter, randomized, double-blinded, parallel-group Phase III clinical study to compare the clinical efficacy, safety, and immunogenicity of 9MW0311 and Prolia® in Chinese postmenopausal women with osteoporosis at high risk for fracture.
详细描述
278 patients are randomized 1:1 to receive 9MW0311 and Prolia® every 6 months for 12 months. The primary efficacy endpoint is the percentage change from baseline in BMD at the lumbar spine(LS) in month 12.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •* Women who can walk freely (≥50 and ≤80 years);
- •* As measured by DXA, the absolute value of BMD at lumbar spine, femoral neck or total hip was -4.0\2 years or \>2 years after bilateral oophorectomy. If the status of bilateral oophorectomy is unknown or if the ovaries are preserved after hysterectomy, follicle stimulating hormone (FSH) levels \>40mIU/mL may be used to confirm the status of postoperative menopause.
排除标准
- •Bone/metabolic disease
- •Hyperparathyroidism or hypoparathyroidism
- •Thyroid condition: Hyperthyroidism or hypothyroidism
- •Rheumatoid arthritis
- •Malignant tumors
- •Malabsorption syndrome
- •Liver cirrhosis, active hepatitis B or hepatitis C, and unstable liver disease; serum aspartate aminotransferase and alanine aminotransferase ≥ 2.0 times the upper limit of normal (ULN); alkaline phosphatase or total bilirubin ≥ 1.5 ULN;
- •Renal disease - severe impairment of kidney function
- •Clinically significant cardiovascular and cerebrovascular diseases (such as myocardial infarction, unstable angina or stroke, NYHA class III or IV heart failure in the 12 months prior to screening) and hematopoietic system disease judged by the investigator;
- •Hypercalcemia or hypocalcemia ;
- •vitamin D deficiency (25-hydroxyvitamin D, 25OHD <20 ng/mL);
- •Oral or dental diseases: previous or current evidence of mandibular osteomyelitis or osteonecrosis; Acute dental or mandibular disease requiring oral surgery; Planning invasive dental surgery; Failure to recover from dental or oral surgery;
- •Use of intravenous bisphosphonates within the previous 2 years;
- •oral bisphosphonates (used for at least 2 years, or used for less than 2 years but more than 3 months, with the last use occurring <1 year before the screening);
- •Use of any of the following drugs within 6 weeks prior to screening that may affect bone metabolism:
- •parathyroid hormone (PTH) or PTH derivatives, such as teriparatide;
- •anabolic hormones or testosterone;
- •glucocorticoids (equivalent dose more than 5mg/ day of prednisone and continuous use for more than 10 days);
- •Selective estrogen receptor modulators (SERMs), such as raloxifene;
- •Menopausal hormone therapy (such as estrogen, estrogen + progesterone, tibolone);
- •Active vitamin D and its analogues (cumulative use of more than 30 days);
- •Other bone-active drugs include antiepileptic drugs (except benzodiazepines) and heparin;
- •Long-term systemic use of ketoconazole, adrenocorticotropin (ACTH), aluminum, lithium, protease inhibitors, methotrexate, gonadotropin releasing hormone agonists;
- •Chinese patent medicines for osteoporosis related treatment are clearly described in the instructions, such as Xianling Gubao capsule (tablet), Gushukang capsule (granule), Jintiange capsule and Qianggu capsule."
- •History of more than two vertebral fractures.
研究组 & 干预措施
9MW0311
Experimental
9MW0311 Denosumab injection(60 mg)
干预措施: 9MW0311 (Drug)
Prolia®
Active Comparator
Prolia® Denosumab injection(60 mg)
干预措施: Prolia® (Drug)
结局指标
主要结局
Percent Change From Baseline in lumbar spine(LS)-BMD at Week 53 （Month 12)
时间窗: Baseline and 12 months
Percent Change From Baseline in LS-BMD at Week 53 （Month 12)
次要结局
- ADA positive rate and ADA titer (if applicable)(Baseline and Month 1, Month3, Month6, Month12)
- Percent change in BMD at the total hip, femoral neck from Baseline up to week 27 (Month 6) and Week 53 (Month 12 )(Baseline, Month6 and Month 53)
- Percent Change in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) and Serum type I procollagen N-terminal propeptide (s-PINP) from Baseline up to 12 months(Baseline, Month1, Month3, Month6, Month9 and Month 12)
- Proportion of subjects with new fragility fractures (e.g., vertebrae, hip, non-vertebrae)(From baseline to Month12)
- Percent Change From Baseline in LS-BMD at Week 27 （Month 6)(Baseline and Month 6)
- Number of participants with AE, SAE, with abnormal vital signs, abnormal physical examination findings, abnormal oral examination findings, abnormal laboratory tests results and abnormal 12-lead ECG readings(From baseline to Month12)
- NAb positive rate (if applicable)(Baseline and Month 1, Month3, Month6, Month12)
研究者
研究点 (1)
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