NCT03002428已完成3 期
A Randomized Study Comparing the Effects of PF708 and Forteo in Patients With Osteoporosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfenex, Inc
- 入组人数
- 181
- 试验地点
- 10
- 主要终点
- Blood levels of anti-drug antibody (ADA) against teriparatide
研究概览
简要总结
The purpose of this study is to compare the effects of two teriparatide products, PF708 and Forteo, in patients with osteoporosis.
详细描述
This is a randomized, multi-center study conducted in the United States. Men and women with osteoporosis will be enrolled in a parallel-group, open-label study design to compare the effects of PF708 and Forteo after 24 weeks of treatment. Half of the subjects will be randomized to receive PF708, and the other half will be randomized to receive Forteo.
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
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •If female, ≥5 years postmenopausal at the time of screening, with a DXA-derived BMD value at least 1 standard deviation (SD) below the average of young, healthy women
- •If male, has a DXA-derived BMD value at least 2 SD below the average of young, healthy men
- •Able to use the pen injection device correctly
- •Able to understand and sign the written Informed Consent Form (ICF)
排除标准
- •Treatment with oral bisphosphonates (once daily or once weekly) within 6 months of screening
- •Any current or prior human PTH-derived products (e.g., Forteo, Teribone, Natpara), including for investigational purposes
- •Immobility due to severe or chronically disabling conditions (e.g., stroke, Parkinson's disease, multiple sclerosis)
- •History of metabolic bone diseases other than osteoporosis
- •History of malignant disease, including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured)
- •History of Paget's disease of bone
- •History of prior external beam or implant radiation therapy involving the skeleton
- •Active urolithiasis or primary hyperparathyroidism
研究组 & 干预措施
Teriparatide (PF708)
Experimental
PF708 20 mcg once-daily subcutaneous injection for 24 weeks
干预措施: Teriparatide (PF708) (Drug)
Teriparatide (Forteo)
Active Comparator
Forteo 20 mcg once-daily subcutaneous injection for 24 weeks
干预措施: Teriparatide (Forteo) (Drug)
结局指标
主要结局
Blood levels of anti-drug antibody (ADA) against teriparatide
时间窗: 24 weeks
次要结局
- Mean percentage change in lumbar-spine bone mineral density (BMD)(24 weeks)
- Median percentage change in serum N-terminal propeptide of type 1 procollagen (P1NP)(24 weeks)
- Median percentage change in serum crosslinked C-terminal telopeptide of type 1 collagen (CTX)(24 weeks)
- Plasma maximum concentration (Cmax) of teriparatide(4 hours)
- Plasma area-under-the-curve (AUC) of teriparatide(4 hours)
研究者
研究点 (10)
Loading locations...
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