NCT07062978招募中3 期
A Multicenter, Randomized, Double-blind Comparative Study to Valuating the Efficacy and Safety of QL1206 and Prolia® in Postmenopausal Women With Osteoporosis at High Risk of Fracture
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 278
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline in lumbar spine(LS)-BMD at Month 12
研究概览
简要总结
This study is a multicenter, randomized, double-blind comparative study to valuating the efficacy and safety of QL1206 and Prolia® in postmenopausal women with osteoporosis at high risk of fracture.
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 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects who agree to participate in the study and sign the informed consent form.
- •Postmenopausal women who can walk freely, aged 50-85 years (including 50 and 85 years old).
- •Subjects whose absolute value of bone mineral density (BMD) in the lumbar or total hip area meets T values ≤ -2.5 and > -4.
- •Subjects who must have at least one of the following risk factors: History of previous fragility fractures (occurring after the age of 40); history of hip fractures in fathers or mothers; increased bone turnover rate during screening; low body weight (BMI ≤ 19 kg/m2); advanced age (aged ≥ 65 years); current smoke.
- •The duration of spontaneous amenorrhea was >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.
- •Malabsorption syndrome.
- •Renal disease - severe impairment of kidney function.
- •Vitamin D defViciency (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.
- •Previously used denosumab drugs.
- •Use of intravenous bisphosphonates, fluoride, or strontium to treat osteoporosis within the last 5 years.
- •OOral bisphosphonates (used for at least 3 years, or used for less than 3 years but more than 3 months, with the last use occurring <1 year before the ICF).
- •Use of any of the following drugs within 6 weeks prior to screening that may affect bone metabolism.
- •History of more than two vertebral fractures.
- •Malignant tumors.
研究组 & 干预措施
QL1206
Experimental
QL1206 Denosumab injection(60 mg)
干预措施: QL1206 (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 Month 12
时间窗: Baseline and 12 months
Percent Change From Baseline in lumbar spine(LS)-BMD at Month 12
次要结局
未报告次要终点
研究者
研究点 (1)
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