NCT01604057Unknown2 期
A Parallel Group Study to Evaluate the Effect of Six Weeks of Treatment With Nasal Spray (NS) ZT-034, Compared to Subcutaneous (SC) Forteo and Placebo, on Bone Formation, as Assessed by Stimulation of Serum P1NP Levels in Postmenopausal Women With Low Bone Mass
Azelon Pharmaceuticals0 个研究点目标入组 130 人开始时间: 2011年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 130
- 主要终点
- Change in Serum P1NP from baseline to end of treatment.
研究概览
简要总结
This study is being conducted to evaluate the effect treatment has on serum P1NP levels, a biomarker of bone formation in postmenopausal women with low bone mass.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal Females Age ≥ 45 years.
- •Weight > 45 kg and < 90 kg
- •Normal nasal examination at baseline.
- •Low bone mass at lumbar spine, total hip or femoral neck (BMD T-score of ≤ - 1.5 or lower) or a recent (within 5 years of baseline) history of fragility fracture (excluding fractures of hands, feet, face and/or skull) and a T-score of -1.0 or lower at lumbar spine, total hip or femoral neck
排除标准
- •Serious Medical Condition
- •History of diseases which affect bone metabolism other than postmenopausal osteoporosis such as Paget's disease, any secondary causes of osteoporosis, hypoparathyroidism, or hyperparathyroidism
- •Have a history of cancer within the past 5 years, except for basal cell carcinoma
- •Have hypocalcemia or hypercalcemia from any cause or have a recent history of kidney stones or pre-existing hypercalciuria;
- •Have used any of the mostly commonly prescribed osteoporosis medications within 3 months of starting the investigational product, or for more than 1 month at any time within 6 months prior to starting investigational product
研究组 & 干预措施
Low Dose Nasal Spray
Experimental
干预措施: ZT-034 Low Dose Nasal Spray (Drug)
Mid Dose Nasal Spray
Experimental
干预措施: ZT-034 Mid Dose Nasal Spray (Drug)
High Dose Nasal Spray
Experimental
干预措施: ZT-034 High Dose Nasal Spray (Drug)
Placebo Nasal Spray
Placebo Comparator
干预措施: Placebo (Drug)
Forteo
Active Comparator
20ug subcutaneous injection daily
干预措施: Teriparatide (Drug)
结局指标
主要结局
Change in Serum P1NP from baseline to end of treatment.
时间窗: 6 weeks
次要结局
- Change in serum calcium and incidence of hypercalcemia (pre-dose and post-dose)(baseline and 6 weeks)
研究者
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