A Double Blind, Randomized, Repeat Dose Parallel Group Study of Recombinant Human Parathyroid Hormone Analog Tablets, or Placebo Tablets, Compared to Open Label Forsteo® in Postmenopausal Women With Osteoporosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- % Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24
研究概览
简要总结
This study is designed to provide information about the bone anabolic properties and absorption profile of Unigene's PTH Analog when administered as oral tablets over a period of 24 weeks to postmenopausal women with osteoporosis.
详细描述
The choice of a 24-week treatment period was based on published studies of PTH which demonstrate its potential to produce a statistically significant increase in BMD in patients with postmenopausal osteoporosis within that observation period.
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
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy postmenopausal women (45-80 years old) with a diagnosis of osteoporosis
排除标准
- •Use of estrogen or hormone replacement therapy
- •Use of bisphosphonates, strontium ranelate or denosumab
- •Use of parathyroid analogues or other bone metabolic agents
- •Medical conditions which might alter bone metabolism
- •Any known clinically significant disease affecting calcium metabolism or history of metabolic disorders including Paget's disease, osteogenesis imperfecta, or osteomalacia
- •Impairment of thyroid function
研究组 & 干预措施
PTH analog tablet
PTH(1-31) 5 mg tablet, once daily
干预措施: PTH analog (Drug)
Placebo
Placebo matching tablet, once daily
干预措施: Placebo (Drug)
Forsteo
Forsteo (teriparatide) 20 mcg SC Injection, once daily
干预措施: Forsteo (Teriparatide) (Drug)
结局指标
主要结局
% Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24
时间窗: 24 weeks from baseline
次要结局
- % Change From Baseline in Bone Resorption Marker (CTx-1) at Week 24(24 weeks from baseline)
- Systemic Absorption of PTH at Week 24(24 weeks)
- % Change From Baseline in Bone Formation Marker (P1NP) at Week 24(24 weeks from baseline)