NCT00535860已完成2 期
A Multicenter, Randomized, Parallel Study to Assess the Clinical Efficacy, Safety, and Tolerability of ViaDerm-hPTH (1-34) in Comparison to Subcutaneous Injection of Forteo in Postmenopausal Women With Osteoporosis
TransPharma Medical10 个研究点 分布在 3 个国家目标入组 104 人开始时间: 2008年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 10
- 主要终点
- Change from baseline to endpoint 96 days in procollagen 1 N-terminal propeptide (P1NP)
研究概览
简要总结
The purpose of this study is to assess the clinical efficacy, safety, and tolerability of ViaDerm-shPTH [1-34] transdermal delivery in comparison to subcutaneous injection of rhPTH[1-34] following 3-month treatment in postmenopausal women 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
50 mcg
Experimental
ViaDerm transdermal delivery
干预措施: Teriparatide (Drug)
80 mcg
Experimental
Add Via-Derm transdermal delivery
干预措施: Teriparatide (Drug)
20 mcg
Active Comparator
Subcutaneous injection
干预措施: Teriparatide (Drug)
结局指标
主要结局
Change from baseline to endpoint 96 days in procollagen 1 N-terminal propeptide (P1NP)
时间窗: Baseline, 96 days
次要结局
- Change from baseline in C-terminal telopeptide of type I collagen (CTX-1.)(Baseline, 96 days)
- hPTH (1-34) Pharmacokinetic AUC of ViaDerm-hPTH (1-34) and teriparatide SC.(Baseline, 96 days)
- Ratio of hPTH (1-34) AUC of transdermal treatment and subcutaneous injection(Baseline, 96 days)
- Ratio of hPTH (1-34) Cmax of transdermal treatment and subcutaneous injection(Baseline, 96 days)
- hPTH (1-34) Pharmacokinetic Cmax of ViaDerm-hPTH (1-34) and teriparatide SC.(Baseline, 96 Days)
- Percentage of patients with serum total calcium above the upper limit of normal range(Over 96 days)
- Percentage of patients with serum total calcium more than 1 mg/dl above the upper limit of normal range(Over 96 days)
- Number of participants with hPTH (1-34) specific antibody immune response(Baseline, 96 days)
- Draize score for erythema and edema(Over 96 Days)
- Visual Analog Scale (VAS) pain assessment(Over 96 days)
研究者
研究点 (10)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety Study for the Treatment of Dysfunctional Uterine BleedingMetrorrhagiaNCT00307801Bayer231
已完成
3 期
Efficacy and Safety Study for the Treatment of Dysfunctional Uterine BleedingMetrorrhagiaNCT00293059Bayer190
已完成
3 期
Pioglitazone Add-on Study in Patients With Type 2 Diabetes MellitusDiabetes Mellitus, Type 2NCT00086502Merck Sharp & Dohme LLC353
已完成
3 期
Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-020)(COMPLETED)Diabetes Mellitus, Type IINCT00086515Merck Sharp & Dohme LLC701
已完成
3 期
Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-021)Diabetes Mellitus, Type 2NCT00087516Merck Sharp & Dohme LLC741