A Multicenter, Randomized, Open-label, Parallel Controlled, Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of SAL056 (Teriparatide for Injection ) in the Treatment of Postmenopausal Women With Osteoporosis at High Fracture Risk
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 493
- 试验地点
- 1
- 主要终点
- Percent Change in Bone Mineral Density (BMD) of Lumbar Spine from Baseline to 48 Weeks
研究概览
简要总结
To Evaluate the Efficacy and Safety of SAL056 for Postmenopausal Women with Osteoporosis at High Fracture Risk
详细描述
The trial consists of a screening period (4 weeks), an open-label treatment period (up to 48 weeks), and a follow-up period (1 weeks), totaling approximately 53 weeks. Subjects who withdraw early will be asked to complete an end of treatment visit, and a safety follow-up visit 2 weeks after the end of treatment visit.
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
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women with the ability to live independently (≥45 and ≤80 years);
- •The patient has a body mass index(BMI) of 18.0 kg/m2 to 30 kg/m2； The patient has one of the following diagnostic criteria for osteoporosis and subject has at least 2 consecutive vertebrae region (L1 to L4) that are evaluable by dual-energy x-ray absorptiometry (DXA)，a) History of hip/vertebra fragility fracture and bone mineral density (BMD) T-score ≤-1; b）the axial bone (lumbar , femoral neck or total hip) mineral density (BMD) T-score ≤-2.50;c) Bone mineral density (BMD) T-score ≥-2.5 and ≤-1 with proximal humerus, pelvis, or distal forearm end fragility fracture
排除标准
- •In addition to postmenopausal osteoporosis, the other diseases affecting bone metabolism;
- •Patients with other diseases affecting calcium or bone metabolism;
- •Received anti-osteoporosis treatment that does not meet protocol requirements;
- •Received medication that affects bone metabolism prior to screening, or is planned to use prohibited drugs/non-drug therapy under the protocol during the study period;
- •Patients requiring long-term or continuous use of digoxin and other digitalis drugs during the trial;
- •Patients with other severe underlying diseases； Patients with abnormal indicators that does not meet protocol requirements during the screening periodlaboratory tests
研究组 & 干预措施
Drug: SAL056 (56.5μg)
Administered by subcutaneous injection once a week during treatment phase
干预措施: SAL056 (56.5μg) (Drug)
Drug: Alendronate
70 mg tablet taken once a week during treatment phase
干预措施: Alendronate (Drug)
结局指标
主要结局
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine from Baseline to 48 Weeks
时间窗: Baseline to 48 Weeks
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine from Baseline to 48 Weeks
次要结局
- Percent Change in Bone Mineral Density (BMD) of Lumbar Spine from Baseline to 24 Weeks(Baseline to 24 Weeks)
- Percent Change in Bone Mineral Density (BMD) of Total Hip from Baseline to 24/48 Weeks(Baseline to 24/48 Weeks)
- Percent Change in S-CTX and P1NP From Baseline to12/ 24/48 Weeks(Baseline to 12/24/48 Weeks)
- Proportion of Subjects with New Fragility Fractures from Baseline to 24/48 Week(Baseline to 24/48 Weeks)