NCT00525798已完成3 期
A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Salmon Calcitonin in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D
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
- 4,665
- 试验地点
- 16
- 主要终点
- Number of Patients With New Vertebral Fractures
研究概览
简要总结
The purpose of this Phase III study is to evaluate the efficacy and safety of oral salmon calcitonin in the treatment of patients with osteoporosis
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
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women with osteoporosis, ambulatory, in general good health, not receiving medication that affects bone metabolism, and free from any underlying condition, other than osteoporosis, that may result in abnormal bone metabolism.
排除标准
- •BMD T-score below -4.0 (based on absolute values g/cm2 as given in the protocol) at one or more of the measured sites
- •More than 2 prevalent vertebral fractures (Genant et al, 15).
- •If BMD is lower than -2.5 T-score at one or more of the measured sites, the participants will be excluded from the study, if they have a severe vertebral fracture (Genant et al, 15).
- •Evidence of any clinical osteoporotic fracture and/or if they have a history of a clinical osteoporotic fracture (excluding wrist fractures)
- •BMD T-score > -1.5 in all of the following regions: Lumbar spine, femoral neck or total hip.
- •Other protocol defined inclusion/exclusion criteria may apply
研究组 & 干预措施
1
Active Comparator
SMC021 - Oral Calcitonin
干预措施: SMC021 Oral calcitonin (Drug)
SMC021- Placebo
Placebo Comparator
SMC021 - placebo
干预措施: SMC021 Placebo (Drug)
结局指标
主要结局
Number of Patients With New Vertebral Fractures
时间窗: From baseline to month 36
The primary variable was the occurrence or not of a new vertebral fracture during the 3 year observation period. New vertebral fractures were identified from an assessment of x-ray of the lateral spine through time (at baseline and at yearly intervals thereafter). The outcome is the number of new vertebral fractures from baseline to 36 months.
次要结局
- Number of Patients With Non-vertebral Fractures(From baseline to month 36)
研究者
研究点 (16)
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