NCT06898060尚未招募3 期
A Multicenter, Randomized, Open-label, Parallel Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of Abaloparatide Injection (QLG2128) in the Treatment of Postmenopausal Women With Osteoporosis and at High Risk of Fracture
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 282
- 主要终点
- Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 52 Week
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of QLG2128 in the treatment of postmenopausal women with osteoporosis and 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
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women who can walk freely (≥50 and ≤85 years);
- •The patient has a body mass index(BMI) of 17.0 kg/m2 to 30 kg/m2；
- •The patient has a bone mineral density T-score≤-2.5 and > -5.0 at the lumbar spine (L1-L4) or femoral neck or total hip by dual energy x-ray absorptiometry (DXA)；
- •The patient has at least one of the following high risk factors of fracture: 1) history of previous fragility fractures; 2) family history of hip fragility fracture; 3) age≥70 years; 4) BMI≤19.0 kg/m2；5) Currently smoking.
- •The patient with at least 2 consecutive vertebrae(L1 to L4) and at least 1 hip can be evaluated for BMD.
排除标准
- •In addition to postmenopausal osteoporosis, the other diseases affecting bone metabolism；
- •History of osteosarcoma；
- •History of orthostatic hypotension；
- •Currently suffering from active urinary calculus；
- •Received anti-osteoporosis treatment that does not meet protocol requirements；
- •Received medication that affects bone metabolism within 4 weeks prior to screening, or is planned to use prohibited drugs/non-drug therapy under the protocol during the study period.
研究组 & 干预措施
QLG2128
Experimental
干预措施: QLG2128 (Drug)
Teriparatide Injection
Active Comparator
干预措施: Teriparatide Injection (Drug)
结局指标
主要结局
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 52 Week
时间窗: Baseline to 52 Week
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 52 Week
次要结局
- Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 26 Week(Baseline to 26 Week)
- Percent Change in Bone Mineral Density (BMD) of Total Hip, Femoral Neck From Baseline to 26/52 Week(Baseline to 26/52 Week)
- Proportion of Subjects With New Fragility Fractures From Baseline to 26/52 Week(Baseline to 26/52 Week)
研究者
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