NCT01224717已完成1 期
A Phase I, Partially Blinded, Randomized, Placebo Controlled, Active Comparator Study to Explore the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Post-menopausal Women After Daily Oral Doses of PTH134
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Measure: Effects of treatment on bone biomarkers. Measure levels of PINP, CTX-1, and serum calcium levels, serum phosphate, P1CP, bone-specific alkaline phosphatase, osteocalcin.
研究概览
简要总结
This study is designed to provide information about the bone-anabolic response of PTH134 when administered orally, in comparison to Forsteo®, the sub-cutaneous form of teriparatide, the active ingredient in PTH134.
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
- •Post-menopausal women osteoporotic/osteopenic with an additional risk factor 45 to 80 years old
排除标准
- •Use of estrogen or hormone replacement therapy
- •Use of parathormone or parathormone fragments, calcitonin, aluminum supplements, within 12 months prior to first dose.
- •Use of bisphosphonates and strontium ranelate
- •Cancer or history of malignancy of any organ system
- •Any radiation therapy to the skeleton.
- •Any known clinically significant disease affecting calcium metabolism. Any history of metabolic disorders including Paget's disease, osteogenesis imperfecta, or osteomalacia.
- •History or clinical evidence of any impairment of thyroid function
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
PTH134
Experimental
干预措施: PTH134 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Forsteo
Active Comparator
干预措施: Forsteo (Drug)
结局指标
主要结局
Measure: Effects of treatment on bone biomarkers. Measure levels of PINP, CTX-1, and serum calcium levels, serum phosphate, P1CP, bone-specific alkaline phosphatase, osteocalcin.
时间窗: 12 weeks
次要结局
- Change from baseline in serum calcium levels after 12 weeks of treatment(12 weeks)
研究者
研究点 (1)
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